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Adavosertib

Enzyme Inhibitors

Patients will receive a single administration of \[14C\]adavosertib as an oral solution on Day 1.

Patients will receive a single administration of \[14C\]Adavosertib as an oral solution on Day 1.

[14C]Adavosertib

This is a non-randomised study in patients with advanced solid malignancies

The aim is to recruit approximately 8 patients with a minimum number of 4 pharmacokinetics (PK) evaluable patients.

Each patient will be admitted to the study site pre-dose on Day -1 and will remain at the study site until at least Day 8. Patients will receive a single administration of \[14C\]adavosertib as an oral solution on Day 1. During this study, whole blood, plasma, urine, faeces, and vomit samples (if presented) will be collected at various time points to characterise the absorption, distribution, metabolism, excretion and PK of adavosertib.

The duration of the residential period will be evaluated following treatment of the first patient and may be adjusted to ensure recovery of at least 90% of the total radioactivity following the dose of \[14C\]adavosertib and/or until less than 1% of dose is recovered in urine and/or faeces within a 24-hour period.

Human Absorption, Distribution, Metabolism, and Excretion Study of [14C]Adavosertib

A Phase I, Open-Label, Non-Randomised Study of the Absorption, Distribution, Metabolism, and Excretion of Adavosertib After a Single Oral Dose of [14C]Adavosertib to Patients With Advanced Solid Tumours

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Assessment of the mass balance of total radioactivity, including the routes and rates of elimination following a single oral dose \[14C\]adavosertib.

Assessment of renal clearance of adavosertib, including the routes and rates of elimination following a single oral dose \[14C\]adavosertib.

Assessment of Cmax of adavosertib and total radioactivity following a single oral dose of \[14C\]adavosertib.

Assessment of AUCinf of adavosertib and total radioactivity following a single oral dose of \[14C\]adavosertib.

Assessment of AUClast of adavosertib and total radioactivity following a single oral dose of \[14C\]adavosertib.

Assessment of tmax of adavosertib and total radioactivity following a single oral dose of \[14C\]adavosertib.

Assessment of λz of adavosertib and total radioactivity following a single oral dose of \[14C\]adavosertib.

Assessment of t½λz of adavosertib and total radioactivity following a single oral dose of \[14C\]adavosertib.

Assessment of CL/F of adavosertib and total radioactivity following a single oral dose of \[14C\]adavosertib.

Assessment of MRTinf of adavosertib and total radioactivity following a single oral dose of \[14C\]adavosertib.

Assessment of Vss/F of adavosertib and total radioactivity following a single oral dose of \[14C\]adavosertib.

Assessment of Vz/F of adavosertib and total radioactivity following a single oral dose of \[14C\]adavosertib.

Assessment of AUCinf plasma adavosertib:Total plasma radioactivity ratio following a single oral dose of \[14C\]adavosertib.

Assessment of AUCinf Blood:Plasma Ratio total radioactivity following a single oral dose of \[14C\]adavosertib.

Assessment of unchanged adavosertib following a single oral dose of \[14C\]adavosertib.

Assessment of CLR of adavosertib and total radioactivity following a single oral dose of \[14C\]adavosertib.

Assessment of the safety and tolerability of adavosertib following oral dosing in patients with advanced solid tumours.

Parexel

AstraZeneca

Symptoms and General Pathology

All Conditions

Neoplasms

Substance Related Disorders

Rare Diseases

Syndrome

Carcinoid Tumor

Malignant Carcinoid Syndrome

Serotonin Syndrome

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Carcinoid Syndrome

Neuroendocrine Tumor

Neuroepithelioma

All subjects will receive a single oral 500 mg dose of \[14C\]-LX1606.

500 mg dose of LX1606 containing a target dose of 3.32 Megabecquerel (MBq) of radiation as \[14C\]-LX1606.

500 mg [14C]-LX1606

Doug Fleming, MD

To evaluate the metabolism and routes and extent of elimination of telotristat etiprate and its primary metabolite LX1033.

An Open-label Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-Telotristat Etiprate in Males

A Phase 1, Open-label, Non-randomised, Single-dose Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-Telotristat Etiprate (LX1606) in Healthy Male Subjects

Lexicon Pharmaceuticals

Gland and Hormone Related Diseases

Thyroid Neoplasms

Thyroid Diseases

Hypothyroidism

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Herbal and Botanical

Hormones

Synthroid will be administered with 12 ounces of black coffee for a period of 6 weeks.

Synthroid will be administered with 12 ounces of coffee and 2 ounces of 2% milk for a period of 6 weeks.

Synthroid will be administered with 12 ounces of black Lipton tea for a period of 6 weeks.

Synthroid will be administered with 12 ounces of water for a period of 6 weeks.

Taking Synthroid with 12 ounces of black coffee for 6 weeks.

Black Coffee

Taking Synthroid with 12 ounces of black coffee and 2 ounces of 2% milk for a period of 6 weeks.

Coffee with Milk

Taking Synthroid with 12 ounces of black tea for a period of 6 weeks.

Black Tea

Taking Synthroid with water for a period of 6 weeks.

Water

Dorota Krajewski, MD

The purpose of this study is to evaluate whether taking thyroid hormone medication with beverages other than water, decreases absorption of the medication by the intestine. Specifically we are interested in whether coffee, coffee with milk, or black tea affects how thyroid medication is absorbed by the body. Previous studies have suggested that taking thyroid hormone with coffee may interfere with the ability to absorb thyroid medicine. Given that many patients take their thyroid medicine with beverages other than water, and specifically with coffee or tea, understanding whether and how much coffee or tea may decrease thyroid hormone absorption is important for clinical practice.

This study will help determine the safest and most effective way for adults to take their thyroid medication and will guide medical practitioners in how to counsel their patients when they prescribe thyroid hormone.

Previous studies have suggested that taking thyroid replacement therapy with coffee potentially hinders its absorption. We already know that food especially a fiber-rich diet, cholestyramine resin, aluminum containing antacids, activated charcoal, and certain herbal remedies among others interfere with the ability to absorb thyroid medicine. These findings have prompted providers to advise patients to take their levothyroxine on an empty stomach in the morning. However, many patients take their thyroid medicine with their morning cup of coffee prior to eating breakfast. A small study has shown that Italian espresso coffee can decrease the absorption of levothyroxine, but the effect of American style coffee is not known. Given that the intestinal absorption of levothyroxine can be hindered by multiple substances and coffee is the most commonly consumed beverage worldwide, it is important to investigate what effect coffee may have on thyroid hormone absorption and thyroid function tests.

Using methods similar to those used in previous studies, this study will measure thyroid function tests in approximately 10-20 subjects (18-60 years of age) over a 6 hour period of time after taking their thyroid medication with the specified study beverage for a 6 week period. Subjects will be randomized to water, black coffee, coffee with milk, and black tea as four specified study beverages, with water serving as the control beverage. Each subject will be recruited to participate with each study beverage for a 6 week period of time in a total of four consecutive 6 week periods. Blood draws will occur at the end of each 6 week period on test days 1, 2, 3, and 4. The coffee will represent the most common household coffee brand, Folgers. Thyroid function tests with each beverage will be compared to thyroid function tests with water to determine if thyroid medication absorption is impaired by coffee, coffee with milk, or tea.

This study will help determine the safest and most efficacious way for adults to take their thyroid medication and will guide medical practitioners in how to counsel their patients when they prescribe thyroid replacement therapy.

The Effect of Coffee on the Absorption of Thyroid Hormone in Patients With Thyroid Carcinoma

The Effect of Coffee Consumption on the Intestinal Absorption of Levothyroxine Thyroid Hormone Replacement in Patients With Thyroid Carcinoma

1. change in TSH over 6 hours
2. peak change in TSH over 6 hours

To determine if taking Synthroid for 6 weeks with each of the prescribed study beverages results in a different baseline TSH, reflecting altered absorption of levothyroxine with each particular beverage.

1. Change in total T4 over 6 hours
2. Peak change in total T4 over 6 hours
3. area under the curve (AUC) for total T4

1. Change in free T4 over 6 hours
2. Peak change in free T4 over 6 hours
3. area under the curve (AUC) for free T4

1. Change in total T3 over 6 hours
2. Peak change in total T3 over 6 hours
3. area under the curve (AUC) for total T3

Georgetown University

Medstar Health Research Institute

Antineoplastic Agents

Poly(ADP-ribose) Polymerase Inhibitors

Rucaparib

Each patient will receive a single oral dose of 600 mg \[14C\] rucaparib (approximately 140 µCi) in the fasted state. Patients will be confined at the study site for the collection of blood samples and excreta for a maximum of 13 days, from Day -1. The patient can be discharged sooner than Day 13, if the discharge criteria are met.

After completion of Part I, patients with a deleterious BRCA mutation will have the option to participate in Part II by receiving 600 mg BID rucaparib tablets orally in 28 day cycles until disease progression, unacceptable toxicity, death, or discontinuation for other reasons

Each dosage unit consists of a hard gelatin capsule filled with cold rucaparib camsylate and \[14C\]-rucaparib camsylate salt. Each capsule contains approximately 150 mg rucaparib (free base weight) and approximately 35 µCi of \[14C\]-rucaparib. Each patient will ingest four capsules in the fasted state for a total dose of 600 mg rucaparib (free base weight) with approximately 140 µCi of \[14C\]-rucaparib

C-14 labeled Rucaparib

The purpose of this study is to characterize the mass balance, absorption, metabolism, and elimination pathways of orally administered \[14C\] rucaparib followed by cycle by cycle treatment with rucaparib continuing until disease progression or other reason for discontinuation

This is a Phase 1, open-label, non-randomized, mass balance study in patients with histologically or cytologically confirmed advanced solid tumors. Approximately 6 patients will be enrolled. The study will consist of 2 parts: a mass balance part (Part I) and a rucaparib treatment part (Part II).

Each patient will receive a single oral dose of 600 mg \[14C\] rucaparib (approximately 140 µCi) in the fasted state. Patients will be confined at the study site for the collection of blood samples and excreta for a maximum of 13 days, from Day -1. The patient can be discharged sooner than Day 13, if the discharge criteria are met. If the cumulative recovery of radioactivity exceeds 90% of the administered dose or if radioactivity in urine and feces is \< 1% of the administered dose over a 24 hour period on two consecutive days, as determined by quick counts.

In Part II, the treatment with rucaparib in 28-day cycles will continue until progression of disease, unacceptable toxicity, or other reason for discontinuation.

Absorption, Metabolism, and Excretion Following a Single Oral Dose of [14C]-Rucaparib

An Open-Label, Non-Randomized, Phase I Study to Assess the Absorption, Metabolism, and Excretion Following a Single Oral Dose of [14C]-Rucaparib in Patients With Advanced Solid Tumors

Response will be determined using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 and tumor markers per applicable criteria for a given tumor type

AUC from time zero to the last time point with concentration above the lower limit of quantitation (AUC0-last)

Incidence of Adverse Events (AEs), clinical laboratory abnormalities, and dose modifications

pharmaand GmbH

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Anti-Infective Agents

Glycerol

Decanoic acid

Coconut

Sunflower

Glyceryl Tridecanoate emulsion, single doses (5 g, 10 g, 20 g) to 3 cohorts

Sunflower oil emulsion, single doses (5 g, 10 g, 20 g) to 3 cohorts

Glyceryl Tridecanoate (GT) is the triglyceride form of decanoic acid (DA), a C10 fatty acid. GT belongs to the class of medium chain triglycerides (MCT), which has been accepted as a Generally Recognized As Safe food product by FDA. Decanoic acid, also known as capric acid, occurs naturally in coconut oil (8 - 10%) and palm kernel oil (4%).

Glyceryl Tridecanoate

Sunflower oil emulsion of equal calories.

Placebo

Eu Leong Yong, MD & PhD

The primary aim of the study is to test safety and tolerance of oral intake of GT oil in the form of a non-diary based emulsion (10g of GT per emulsion) in healthy men. This will be a single center study, and the recruitment is expected to happen over a 1-2- month's period.

Polycystic Ovarian Syndrome (PCOS) is a hormonal disorder contributing to infertility in women. PCOS is also associated with Insulin resistance (IR) occurring at a high incidence rate of 50-70%. IR is a condition in which your body loses sensitivity to insulin requiring higher levels of it to maintain normal glucose levels in blood which hormones production from ovaries. Studies have demonstrated that the prevalence of the metabolic syndrome which is a cluster of condition such as increased blood pressure, high blood sugar, excess body fat around the waist, and abnormal cholesterol in women with PCOS is significantly higher than that of the general population. Medications that improve insulin sensitivity, such as thiazolidinediones (TZDs) and Metformin, an insulin sensitizer have been used in treating women with PCOS. Metformin major side effects consist of nausea, vomiting and gastrointestinal distress. TZDs are withdrawn from the market due to their adverse effect profile, which includes liver toxicity, weight gain, swelling due to water retention and cardiovascular diseases. As current treatment options are inadequate, there is a clinical need to identify new treatment regimens with a reduced adverse effect profile to improve the management of PCOS and its related metabolic syndrome.

Glyceryl Tridecanoate (GT) is a medium chain triglyceride (MCT); a form of dietary fat, which has a long history of safe use in in foods, drugs, cosmetics, can even be provided via the veins in individuals requiring supplemental nutrition. Decanoic acid, also known as capric acid, occurs naturally in coconut oil (8 - 10%) and palm kernel oil (4%). Importantly, the published findings show that oral administration of GT, the triglyceride form of decanoic acid, can improve insulin sensitivity and storage and breakdown of fat in animal models of diabetes. Notably, in the investigators' recent findings, DA could reduce androgen production and alleviate PCOS like symptoms in a test-induced PCOS rat model. Hence, there is a high likelihood that GT can improve the management of PCOS without the undesirable side effects that are observed with the thiazolidinediones.

The primary aim of the study is to test safety and tolerance of oral intake of GT oil in the form of a non-diary based emulsion (10g of GT per emulsion) in healthy men. This will be a single center study, and the recruitment is expected to happen over a 1-2- month's period.

Absorption and Tolerability Studies of an Emulsion Containing the Coconut Oil-derived Glycerol Tridecanoate in Healthy Men

Incidence and severity of adverse events/serious adverse events based on history, physical examination and vital signs and clinical chemistry

Serum will be extracted from blood samples for measurement of decanoic acid using gas chromatography-mass spectrometry (GC/MS)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Human Absorption, Distribution, Metabolism, and Excretion Study of [14C]Adavosertib	NCT05008913	Advanced Solid ...	[14C]Adavoserti...	18 Years - 130 Years	AstraZeneca
An Open-label Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-Telotristat Etiprate in Males	NCT01932528	Carcinoid Syndr...	500 mg [14C]-LX...	30 Years - 65 Years	Lexicon Pharmaceuticals
The Effect of Coffee on the Absorption of Thyroid Hormone in Patients With Thyroid Carcinoma	NCT01707056	Thyroid Carcino... Hypothyroidism	Black Coffee Coffee with Mil... Black Tea Water	18 Years - 60 Years	Medstar Health Research Institute
Absorption, Metabolism, and Excretion Following a Single Oral Dose of [14C]-Rucaparib	NCT02986100	Solid Tumor	C-14 labeled Ru... Rucaparib	18 Years -	pharmaand GmbH
Absorption and Tolerability Studies of an Emulsion Containing the Coconut Oil-derived Glycerol Tridecanoate in Healthy Men	NCT03255889	Polycystic Ovar...	Glyceryl Tridec... Placebo	21 Years - 40 Years	National University Hospital, Singapore
Human Absorption, Distribution, Metabolism, and Excretion Study of [14C]Adavosertib	NCT05008913	Advanced Solid ...	[14C]Adavoserti...	18 Years - 130 Years	AstraZeneca
An Open-label Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-Telotristat Etiprate in Males	NCT01932528	Carcinoid Syndr...	500 mg [14C]-LX...	30 Years - 65 Years	Lexicon Pharmaceuticals
Absorption and Tolerability Studies of an Emulsion Containing the Coconut Oil-derived Glycerol Tridecanoate in Healthy Men	NCT03255889	Polycystic Ovar...	Glyceryl Tridec... Placebo	21 Years - 40 Years	National University Hospital, Singapore

Spots Global Cancer Trial Database for absorption

Every month we try and update this database with for absorption cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for absorption

Every month we try and update this database with for absorption cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for absorption cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.