Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Breast Neoplasms

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Anti-Arrhythmia Agents

Cardiotonic Agents

All Drugs and Chemicals

Lipid Regulating Agents

Anti-Infective Agents

Antineoplastic Agents

Bone Density Conservation Agents

Digoxin

Rosuvastatin Calcium

polysaccharide-K

Calcium

Calcium, Dietary

Anticholesteremic Agents

Hypolipidemic Agents

Antimetabolites

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Enzyme Inhibitors

Protective Agents

Participants will receive a single oral dose cocktail containing 0.25 mg digoxin and 10 mg rosuvastatin on Day 1 and 64. A single oral dose of placebo to match enzalutamide will be given on Day 1 and 160 mg enzalutamide once daily on Days 8 through 71.

enzalutamide

enzalutamide Placebo

digoxin

rosuvastatin

Medical Director

The primary purpose of this study is to determine the effect of multiple once daily administrations of enzalutamide on the pharmacokinetics of a single dose of digoxin (P-glycoprotein (P-gp) substrate) and rosuvastatin (breast cancer resistant protein (BCRP) substrate) in participants with prostate cancer.

This study will also evaluate the safety and tolerability of multiple once daily administrations of enzalutamide alone and in combination with a single dose of digoxin (P-gp substrate) and rosuvastatin (BCRP substrate) in participants with prostate cancer, as well, assess the pharmacokinetics of enzalutamide and its active metabolite.

Eligible participants will be admitted to the clinical unit on day -1. Participants may be discharged from the clinical unit on day 2 on the condition that all required assessments have been performed and that there are no medical reasons for a longer stay in the clinical unit and participants are able and willing to return to the clinical unit on days 3 to 8 for daily pharmacokinetic sampling. Or, participants may choose to remain in the clinical unit up to the 168 hour postdose (day 8) pharmacokinetic sample collection.

Participants will return to the clinical unit on day 35 for an ambulant visit and will be admitted to the clinical unit on day 63. Participants may be discharged from the clinical unit on day 65 on the condition that all required assessments have been performed and that there are no medical reasons for a longer stay in the clinical unit and participants are able and willing to return to the clinical unit on days 66 to 71 for daily pharmacokinetic sampling. Or, participants may choose to remain in the clinical unit up to the 168 hour postdose (day 71) pharmacokinetic sample collection.

From day 72 onwards, participants experiencing clinical benefit (determined by the investigator in consultation with the physician responsible for treating the participants' prostate cancer) may roll over into an open label, single arm extension study. Only participants who will be enrolled into the extension study will continue to receive enzalutamide until any discontinuation criterion occurs per the extension study protocol.

A Study to Evaluate the Effect of Multiple Doses of Enzalutamide on the Pharmacokinetics of Substrates of P-glycoprotein (Digoxin) and Breast Cancer Resistant Protein (Rosuvastatin) in Male Subjects With Prostate Cancer

A Phase 1 Open-label Study to Evaluate the Effect of Multiple Doses of Enzalutamide on the Pharmacokinetics of Substrates of P-glycoprotein (Digoxin) and Breast Cancer Resistant Protein (Rosuvastatin) in Male Subjects With Prostate Cancer

Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

Cmax will be recorded from the pharmacokinetic (PK) plasma samples collected.

AUClast will be recorded from the pharmacokinetic (PK) plasma samples collected.

AUCinf will be recorded from the pharmacokinetic (PK) plasma samples collected.

Adverse events (AEs) will be coded using medical dictionary for regulatory activities (MedDRA).

An AE is any untoward medical occurrence in a participant administered an Investigational Product (IP), and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of IP whether or not considered related to the IP.

An AE is considered "serious" if the event: results in death; is life-threatening; results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly or birth defect; requires inpatient hospitalization (except for planned procedures)or leads to prolongation of hospitalization (except if prolongation of planned hospitalization is not caused by an AE); or other medically important events.

Number of participants with potentially clinically significant laboratory values.

Number of participants with potentially clinically significant vital sign values.

Number of participants with potentially clinically significant ECG values.

AUCtau will be recorded from the pharmacokinetic (PK) plasma samples collected.

Ctrough will be recorded from the pharmacokinetic (PK) plasma samples collected.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study to Evaluate the Effect of Multiple Doses of Enzalutamide on the Pharmacokinetics of Substrates of P-glycoprotein (Digoxin) and Breast Cancer Resistant Protein (Rosuvastatin) in Male Subjects With Prostate Cancer	NCT04094519	Prostate Cancer	enzalutamide enzalutamide Pl... digoxin rosuvastatin	18 Years -	Astellas Pharma Inc
A Study to Evaluate the Effect of Multiple Doses of Enzalutamide on the Pharmacokinetics of Substrates of P-glycoprotein (Digoxin) and Breast Cancer Resistant Protein (Rosuvastatin) in Male Subjects With Prostate Cancer	NCT04094519	Prostate Cancer	enzalutamide enzalutamide Pl... digoxin rosuvastatin	18 Years -	Astellas Pharma Inc

Spots Global Cancer Trial Database for enzalutamide placebo