Neoplasms

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

All Conditions

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Rare Diseases

Neurofibromatoses

Neurofibromatosis 1

Neurofibroma

Neurofibroma, Plexiform

Nerve Sheath Neoplasms

Neoplasms, Nerve Tissue

Neoplasms by Histologic Type

Syndrome

Neoplastic Syndromes, Hereditary

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Peripheral Nervous System Diseases

Neuromuscular Diseases

Nervous System Neoplasms

Peripheral Nervous System Neoplasms

Neurofibromatosis

Neurofibromatosis Type 1

Antipyretics

Analgesics

All Drugs and Chemicals

Acetaminophen

Analgesics, Non-Narcotic

Participants will receive Treatment A (selumetinib 25 mg granule, fasted state) in Part 1, Period 1, Treatment B (selumetinib 50 mg capsule, fasted state) in Part 1, Period 2, Treatment C (selumetinib 25 mg granule, fed state) in Part 2, Period 3, and Treatment D (selumetinib 50 mg capsule, fed state) in Part 2, Period 4. Participants will also receive a single 500 mg dose of acetaminophen at the same time as selumetinib administration where it will act as a marker for gastric emptying.

Participants will receive Treatment B (selumetinib 50 mg capsule, fasted state) in Part 1, Period 1, Treatment A (selumetinib 25 mg granule, fasted state) in Part 1, Period 2, Treatment C (selumetinib 25 mg granule, fed state) in Part 2, Period 3 and Treatment D (selumetinib 50 mg capsule, fed state) in Part 2, Period 4. Participants will also receive a single 500 mg dose of acetaminophen at the same time as selumetinib administration where it will act as a marker for gastric emptying.

Participants will receive Treatment A (selumetinib 25 mg granule, fasted state) in Part 1, Period 1, Treatment B (selumetinib 50 mg capsule, fasted state) in Part 1, Period 2, Treatment D (selumetinib 50 mg capsule, fed state) in Part 2, Period 3 and Treatment C (selumetinib 25 mg granule, fed state) in Part 2, Period 4. Participants will also receive a single 500 mg dose of acetaminophen at the same time as selumetinib administration where it will act as a marker for gastric emptying.

Participants will receive Treatment B (selumetinib 50 mg capsule, fasted state) in Part 1, Period 1, Treatment A (selumetinib 25 mg granule, fasted state) in Part 1, Period 2, Treatment D (selumetinib 50 mg capsule, fed state) in Part 2, Period 3 and Treatment C (selumetinib 25 mg granule, fed state) in Part 2, Period 4. Participants will also receive a single 500 mg dose of acetaminophen at the same time as selumetinib administration where it will act as a marker for gastric emptying.

During Part 1 of the study, participants will receive single doses of selumetinib 25 mg granule under fasted conditions. The dose will be administered after an overnight fast of at least 10 hours. The IMP will be administered with approximately 240 mL of water. No food will be allowed for at least 4 hours post-dose.

Treatment A

During Part 1 of the study, participants will receive single doses of selumetinib 50 mg capsule under fasted conditions. The dose will be administered after an overnight fast of at least 10 hours. The IMP will be administered with approximately 240 mL of water. No food will be allowed for at least 4 hours post-dose.

Treatment B

During Part 2 of the study, participants will receive single doses of selumetinib 25 mg granule under fed conditions. Following an overnight fast of at least 10 hours, participants will start consumption of the recommended meal within 30 minutes before administration of the IMP. Participants will be required to consume the entire meal in 30 minutes or less; however, the IMP should be administered 30 minutes after start of the meal. The IMP will be administered with approximately 240 mL of water. No food will be allowed for at least 4 hours post-dose, where after a meal may be provided.

Treatment C

During Part 2 of the study, participants will receive single doses of selumetinib 50 mg capsule under fed conditions. Following an overnight fast of at least 10 hours, participants will start consumption of the recommended meal within 30 minutes before administration of the IMP. Participants will be required to consume the entire meal in 30 minutes or less; however, the IMP should be administered 30 minutes after start of the meal. The IMP will be administered with approximately 240 mL of water. No food will be allowed for at least 4 hours post-dose, where after a meal may be provided.

Treatment D

Participants will receive a single 500mg dose of acetaminophen at the same time.

Ronald Goldwater, MD

This study will evaluate bioavailability and food effect of selumetinib (AZD6244) in healthy male participants. A total of 24 healthy male participants will be included to ensure at least 20 evaluable participants. The study is divided in 2 study parts; the same participants will participate in both parts of the study. Part 1 of the study is to investigate the pharmacokinetics (PK) of the selumetinib granule compared to the PK of selumetinib capsule, when administered with water under the fasted conditions. Part 2 of the study is to investigate the PK of selumetinib granule and capsule under fed conditions. Participants will also receive a single 500 mg dose of acetaminophen at the same time as selumetinib administration.

This study will be a 2-part, open-label, single-center relative bioavailability and food effect randomized crossover study of new granule and capsule formulations of selumetinib. A total of 24 healthy male participants aged between 18 to 45 years (inclusive), will be included to ensure at least 20 evaluable participants. The study is divided in 2 study parts; the same participants will participate in both parts of the study.

Part 1 of the study is designed to investigate the PK of the selumetinib granule compared to the PK of selumetinib capsule, when administered with water under the fasted conditions. Part 2 of the study is designed to investigate the PK of selumetinib granule and capsule under fed conditions. Participants will consume a low-fat, low-calorie meal. Thirty minutes after the start of the meal, selumetinib will be administered to the participants. In all treatment periods, participants will also receive a single 500 mg dose of acetaminophen at the same time as selumetinib administration where it will act as a marker for gastric emptying. The study will also assess the palatability of the selumetinib granule in both parts of the study.

Each participant will receive the following treatments:

* Treatment A: 25 mg granule, fasted state
* Treatment B: 50 mg capsule, fasted state
* Treatment C: 25 mg granule, fed state
* Treatment D: 50 mg capsule, fed state Participant will be randomly assigned to 1 of 4 treatment sequences. In all cases the treatments in Part 1 will be administered before the treatments in Part 2. The study will comprise of a screening period of maximum 28 days. Four treatment periods during which participants will be resident from the day before dosing (Day -1) until at least 48 hours after dosing; discharged on the morning of Day 3. A follow-up visit, will be within 7 to 10 days after the last dose of investigational medicinal product (IMP). There will be a minimum washout period of at least 5 days between each IMP administration. Each participant will be involved in the study for approximately 8 to 9 weeks.

A Study to Evaluate Bioavailability and Food Effect of Selumetinib (AZD6244) in Healthy Male Participants

A Phase I, Open-label, Single-center Relative Bioavailability and Food Effect Randomized Crossover Study of New Granule and Capsule Formulations of Selumetinib (AZD6244) in Healthy Male Subjects

To compare the AUC/D of the new selumetinib granule formulation with selumetinib capsule formulation in fasted state.

To compare the AUClast/D of the new selumetinib granule formulation with selumetinib capsule formulation in fasted state.

To compare the Cmax/D of the new selumetinib granule formulation with selumetinib capsule formulation in fasted state.

To compare the Frel. of the new selumetinib granule formulation with selumetinib capsule formulation in fasted state.

To compare AUC of selumetinib capsule fasted versus capsule low-fat fed state.

To compare AUClast of selumetinib capsule fasted versus capsule low-fat fed state.

To compare AUC (0-12) of selumetinib capsule fasted versus capsule low-fat fed state.

To compare Cmax of selumetinib capsule fasted versus capsule low-fat fed state.

To compare FRAUC of selumetinib capsule fasted versus capsule low-fat fed state.

To compare FRCmax of selumetinib capsule fasted versus capsule low-fat fed state.

To compare t½λz of selumetinib capsule fasted versus capsule low-fat fed state.

To compare tmax of selumetinib capsule fasted versus capsule low-fat fed state.

To compare λz of selumetinib capsule fasted versus capsule low-fat fed state.

To compare CL/F of selumetinib capsule fasted versus capsule low-fat fed state.

To compare Vz/F of selumetinib capsule fasted versus capsule low-fat fed state.

To compare AUC of selumetinib granule fasted versus granule low-fat fed state.

To compare AUClast of selumetinib granule fasted versus granule low-fat fed state.

To compare AUC (0-12) of selumetinib granule fasted versus granule low-fat fed state.

To compare Cmax of selumetinib granule fasted versus granule low-fat fed state.

To compare FRAUC of selumetinib granule fasted versus granule low-fat fed state.

To compare FRCmax of selumetinib granule fasted versus granule low-fat fed state.

To compare t½λz of selumetinib granule fasted versus granule low-fat fed state.

To compare tmax of selumetinib granule fasted versus granule low-fat fed state.

To compare λz of selumetinib granule fasted versus granule low-fat fed state.

To compare CL/F of selumetinib granule fasted versus granule low-fat fed state.

To compare Vz/F of selumetinib granule fasted versus granule low-fat fed state.

To assess palatability of selumetinib granule formulation. The standardized questionnaire will be administered to participants within 10 minutes following intake of selumetinib granule. Questionnaire about taste include sweet, salty, sour, bitter, metallic, and hot/spicy. Where 0 indicates not at all and 10 indicates extremely.

To assess the safety and tolerability of single doses of selumetinib in healthy participants.

To assess systolic BP as a variable of safety and tolerability of single doses of selumetinib in healthy participants. Participants should be supine and at rest for at least 5 minutes before the measurements.

To assess diastolic BP as a variable of safety and tolerability of single doses of selumetinib in healthy participants. Participants should be supine and at rest for at least 5 minutes before the measurements.

To assess pulse rate as a variable of safety and tolerability of single doses of selumetinib in healthy participants.

Participants should be supine and at rest for at least 5 minutes before the measurements.

To assess 12-lead ECG as variable of safety and tolerability of single doses of selumetinib in healthy participants. Participants should be supine and at rest 10 minutes before recording the ECG.

To assess physical examination as a variable safety and tolerability of single doses of selumetinib in healthy participants.

To assess ophthalmic examination as a variable of safety and tolerability of single doses of selumetinib in healthy participants. Ophthalmic examination included best corrected visual acuity, intra-ocular pressure and slit-lamp fundoscopy.

To assess Hb as a variable of safety and tolerability of single doses of selumetinib in healthy participants.

To assess erythrocyte count as a variable of safety and tolerability of single doses of selumetinib in healthy participants.

To assess platelet count as a variable of safety and tolerability of single doses of selumetinib in healthy participants.

To assess leucocyte differential count as a variable of safety and tolerability of single doses of selumetinib in healthy participants.

To assess leucocyte cell count as variable of safety and tolerability of single doses of selumetinib in healthy participants.

To assess differential count of neutrophils, lymphocytes, monocyets, eosinophils and basophils) as a variable of safety and tolerability of single doses of selumetinib in healthy participants.

To assess serum level of sodium, potassium, magnesium and phosphate as a variable of safety and tolerability of single doses of selumetinib in healthy participants.

To assess urea nitrogen as a variable of safety and tolerability of single doses of selumetinib in healthy participants.

To assess creatinine as variable of safety and tolerability of single doses of selumetinib in healthy participants.

To assess albumin as a variable of safety and tolerability of single doses of selumetinib in healthy participants.

To assess total calcium as a variable of safety and tolerability of single doses of selumetinib in healthy participants.

To assess total protein as a variable of safety and tolerability of single doses of selumetinib in healthy participants.

To assess total bilirubin as a variable of safety and tolerability of single doses of selumetinib in healthy participants.

To assess CPK as a variable of safety and tolerability of single doses of selumetinib in healthy participants.

To assess troponin as a variable of safety and tolerability of single doses of selumetinib in healthy participants.

To assess serum of Alkaline phosphatase (ALP), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) and Gamma glutamyl transpeptidase (GGT) as a variable of safety and tolerability of single doses of selumetinib in healthy participants.

To assess urine glucose as a variable of safety and tolerability of single doses of selumetinib in healthy participants.

To assess urine protein as a variable of safety and tolerability of single doses of selumetinib in healthy participants.

To assess urine blood as a variable of safety and tolerability of single doses of selumetinib in healthy participants.

If urinalysis is positive for blood, a microscopy test will be performed to assess RBC, white blood cell \[WBC\], casts \[cellular, granular, hyaline\]).

AstraZeneca

Blood and Lymph Conditions

Immune System Diseases

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Gastrointestinal Agents

Omeprazole

Famotidine

1600 mg GS-9973 (Formulation 1) plus 20 mg omeprazole

1600 mg GS-9973 (Formulation 1) plus 40 mg famotidine

1600 mg GS-9973 (Formulation 2) plus 20 mg omeprazole

Treatment E

1600 mg GS-9973 (Formulation 2) plus 40 mg famotidine

Treatment F

Treatment G

1600 mg GS-9973 (Formulation 1 or Formulation 2, based on results from Part A)

Treatment H

An alternate dose of the chosen formulation from Part A up to 1200 mg administered twice-daily

Treatment I

Treatment J

Michael Hawkins, MD

This is a Phase 1, Open-Label, Adaptive Study of Novel GS-9973 Tablet Formulations to Evaluate the Effect of Acid Reducing Agents, Relative Bioavailability, and Food Effect on GS-9973 Pharmacokinetics.

A Phase 1 Study of Novel GS-9973 Tablet Formulations to Evaluate the Effect of Acid Reducing Agents, Relative Bioavailability, and Food Effect on GS-9973 Pharmacokinetics

A Phase 1, Open-Label, Adaptive Study of Novel GS-9973 Tablet Formulations to Evaluate the Effect of Acid Reducing Agents, Relative Bioavailability, and Food Effect on GS-9973 Pharmacokinetics

The primary outcome measure is the pharmacokinetic (PK) parameters for GS-9973 including AUC and Cmax.

A secondary outcome measure is the pharmacokinetic parameters for GS-9973 including Ctau and AUClast.

A secondary outcome measure is the safety and tolerability of GS-9973 which will be evaluated by the incidence of AEs including assessment of clinical laboratory test findings, physical examinations, 12-lead ECG abnormalities, and vital signs measurements.

A secondary outcome measure is the blood pharmacodynamic parameters.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Evaluate Bioavailability and Food Effect of Selumetinib (AZD6244) in Healthy Male Participants	NCT03649165	Neurofibromatos... Healthy Partici...	Treatment A Treatment B Treatment C Treatment D Acetaminophen	18 Years - 45 Years	AstraZeneca
A Phase 1 Study of Novel GS-9973 Tablet Formulations to Evaluate the Effect of Acid Reducing Agents, Relative Bioavailability, and Food Effect on GS-9973 Pharmacokinetics	NCT01841489	Chronic Lymphoc...	Treatment A Treatment B Treatment C Treatment D Treatment E Treatment F Treatment G Treatment H Treatment I Treatment J	18 Years - 45 Years	Gilead Sciences
A Phase 1 Study of Novel GS-9973 Tablet Formulations to Evaluate the Effect of Acid Reducing Agents, Relative Bioavailability, and Food Effect on GS-9973 Pharmacokinetics	NCT01841489	Chronic Lymphoc...	Treatment A Treatment B Treatment C Treatment D Treatment E Treatment F Treatment G Treatment H Treatment I Treatment J	18 Years - 45 Years	Gilead Sciences

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Spots Global Cancer Trial Database for treatment a

Every month we try and update this database with for treatment a 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 treatment a 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.