Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02138799
Other study ID # 9785-CL-0405
Secondary ID 2012-004841-34
Status Completed
Phase Phase 1
First received May 13, 2014
Last updated October 14, 2014
Start date July 2013
Est. completion date September 2013

Study information

Verified date October 2014
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

This study evaluates how a drug that alters liver enzymes (rifampin) affects the metabolism of enzalutamide in men by measuring concentrations of enzalutamide and its metabolites in plasma.


Description:

The study consists of 2 randomized treatment arms. In both arms the subjects receive a single oral dose of enzalutamide.

In Arm 1 the subjects are admitted to the clinic on Day -1 where they remain until Day 3. Each subject receives a single oral dose of enzalutamide, administered under fasted conditions on Day 1. Ambulant visits take place from Day 4 to Day 50. Full PK profiles are obtained for enzalutamide, Major Inactive Carboxylic Acid Metabolite (M1) and Active Metabolite N-desmethyl Enzalutamide (M2) from Day 1 up to Day 50 after intake of enzalutamide.

In Arm 2 each subject receives a once-daily dose of rifampin on Days 1 to 21. On Day 8, a single oral dose of enzalutamide is administered under fasted conditions concomitantly with rifampin. Full PK profiles are obtained for enzalutamide, M1 and M2 from Day 8 up to Day 57 after intake of enzalutamide.

An End of Study Visit (ESV) takes place between 7 and 10 days after the last PK sample or early withdrawal.

Safety assessments are performed throughout the study.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- Subject has a Body Mass Index (BMI) of at least 18.5 and no greater than 29.9 kg/m2 at screening.

- Subject must use a condom when having sex with a pregnant woman.

- Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of two forms of birth control.

- Male subject must not donate sperm starting at screening and throughout the study period and for 90 days after the final study drug administration.

Exclusion Criteria:

- Subject has a confirmed CYP2C8 poor metabolizer status based on genotyping analysis.

- Subject has a history of seizure or any condition that may predispose to seizure. Historically or currently on any convulsive medication or drugs that may lower the seizure threshold. History of any central nervous system (CNS) infections. Also history of transient ischemic attack or cerebrovascular accident with or without head trauma within 12 months of enrollment (Day -1 visit).

- Subject has any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic admission on Day -1.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science


Intervention

Drug:
enzalutamide
oral
rifampin
oral

Locations

Country Name City State
Germany Parexel International GmbH Berlin

Sponsors (2)

Lead Sponsor Collaborator
Astellas Pharma Europe B.V. Medivation, Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary PK of enzalutamide and the sum of enzalutamide + M2 in plasma measured by area under the curve (AUC) from time 0 to 336 hours after dosing (AUC0-336h) Days 1 to 50 (29 times) No
Primary PK of enzalutamide and the sum of enzalutamide + M2 in plasma measured by AUC extrapolated to infinity (AUCinf) Days 1 to 50 (29 times) No
Secondary PK of enzalutamide, M2, M1 and the sum of enzalutamide + M2 in plasma AUC0-336h, AUCinf, Cmax (M2, M1), time to attain Cmax (tmax), terminal elimination half life (t1/2), AUC up to last quantifiable concentration (AUClast), apparent total body clearance after extra vascular dosing (CL/F), apparent volume of distribution during the terminal phase after extra vascular dosing (Vz/F) (parent compound only), Metabolite-to-Parent Ratio (MPR), percent extrapolated for AUCinf (%AUC) Days 8 to 57 (49 times) No
Secondary PK of rifampin in plasma Cmax, tmax, AUC for the defined interval between doses (AUCtau), minimum concentration (Cmin) Days 6 to 21 (20 times) No
Secondary Safety and tolerability of enzalutamide, alone or in the presence of rifampin vital signs, incidence of adverse events (AE), laboratory assessments, physical examination, electrocardiogram (ECG) Screening (Day -28 to -7) to End of Study Visit (ESV) (>34 times) No
See also
  Status Clinical Trial Phase
Completed NCT05483998 - A Study to Evaluate Single and Multiple Doses of TLC-2716 in Healthy Participants Phase 1
Recruiting NCT02235012 - Cognitive Biases Under Ketamine N/A
Recruiting NCT02417714 - Prospective Evaluation of Next Generation CT Reconstruction (NextGenIR)
Completed NCT05088343 - Effect of Hetrombopag on the Pharmacokinetics of Rosuvastatin in Healthy Subjects Phase 1
Completed NCT04418973 - Analysis of Breath Volatile Organic Compounds After Dyspnea Induced in the Healthy Subject. N/A
Not yet recruiting NCT06248801 - Vildagliptin and Metformin Tablets 50/1000 mg Relative to GALVUS MET (50mg/1000 mg) Tablets Phase 1
Terminated NCT04068259 - Single Ascending Dose Study of PBI-4547 in Healthy Subjects Phase 1
Completed NCT03279302 - Trial to Evaluate the PK Profile of Glepaglutide (ZP1848) After a Single IV and After Multiple SC Injections in Healthy Subjects Phase 1
Not yet recruiting NCT06233162 - Febuxostat 80 mg Tablets Relative to Feburic® 80 mg Tablets Phase 1
Recruiting NCT04159844 - Evaluation of the Stiffness and Pressure Applied on the Lower Leg by a New Compression Bandage on Healthy Subjects N/A
Completed NCT06137911 - Evaluation of Safety, Tolerability & Pharmacokinetics of JYP0061 in Healthy Adults. Phase 1
Completed NCT04849286 - Measurement of HTL0016878 in Cerebrospinal Fluid Phase 1
Not yet recruiting NCT06233227 - Dutasteride Soft Capsule 0.5 mg Relative to Avodart 0.5 mg Soft Capsule Phase 1
Completed NCT04096157 - A Study to Assess Isavuconazole Following a Single Dose of Isavuconazonium Sulfate Intravenous Solution Via Nasogastric (NG) Tube Compared to a Single Dose of Oral Capsules Under Fasting Conditions in Healthy Participants Phase 1
Completed NCT01200368 - Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants Phase 3
Recruiting NCT05805033 - Peri-Implant Soft Tissue Integration in Humans: Influence of Material N/A
Completed NCT04027803 - Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 and Soliris® Phase 1
Recruiting NCT03467880 - Multicenter Study of Impulse Oscillometry in Chinese N/A
Completed NCT02903095 - Single Ascending Dose Study of TD-1439 in Healthy Subjects Phase 1
Active, not recruiting NCT02341508 - A Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate Lpathomab in Healthy Volunteers Phase 1