A Study to Evaluate the Pharmacokinetics of Abiraterone in Healthy Chinese Male Participants

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Treatment A: abiraterone acetate; Drug: Treatment C: abiraterone acetate; Drug: Treatment B: abiraterone acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01678573

ABI-PRO-1016 (Other Identifier)

CR100668

Details and patient eligibility

About

The purpose of this study is to evaluate the pharmacokinetics (how the drug concentrations change over time) of abiraterone acetate after oral administration of abiraterone acetate at different dose levels of 250, 500, and 1000 mg in healthy Chinese male participants under fasted conditions.

Full description

This is an open-label (all people know the identity of the intervention), randomized (the treatment sequence is assigned by chance), 3-way crossover study (method used to switch participants from one dose level to another in a clinical study) of single doses of abiraterone acetate in healthy Chinese male participants. The study consists of 3 phases: screening, open-label treatment, and follow up phases. After screening, randomly assigned participants will receive different dose levels of abiraterone acetate (Treatment A = 250 mg; Treatment B = 500 mg; and Treatment C = 1000 mg) on Day 1 in each of the 3 treatment periods according to a randomized schedule under fasted conditions (Sequence 1 = ABC; Sequence 2 = BAC; and Sequence 3 = CBA). Each treatment period will be separated by a washout period (period when participant is not receiving any study medication) of at least 7 days. In the follow-up phase, study-related adverse events will be monitored by the investigator. Serial blood samples for pharmacokinetic analysis will be collected and safety will be monitored throughout the study. The total study duration will be approximately 42 days.

Enrollment: 15 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body mass index within 18 to 27 kg/m2 (inclusive) and body weight above 50 kg at screening
• Protocol-defined laboratory and electrocardiogram parameters
• Negative test results for selected medications and substances of abuse and negative exhaled carbon monoxide test at check-in day of each period
• Agrees to protocol-defined use of effective contraception
• Willing to be confined at the clinical research facility for time period specified in the protocol

Exclusion criteria

• Significant history or current manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematologic, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
• History of hypersensitivity reaction to the study medication or related compounds or excipients used in the formulation
• Confirmed hepatitis A, B, or C infection or human immunodeficiency virus (HIV) 1 or HIV-2 infection at screening
• Serum testosterone level of <200 ng/dL
• Use of any tobacco or nicotine-containing products
• Known or suspected use of illicit drugs in the last year
• Protocol contraindicated medications/preparations (prescription and non-prescription)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 3 patient groups

Sequence 1: abiraterone acetate

Experimental group

Description:

Randomly assigned participants in Sequence 1 will receive different dose levels of abiraterone acetate (Treatment A = 250 mg; Treatment B = 500 mg; and Treatment C = 1000 mg) on Day 1 in each of the 3 treatment periods according to the randomized schedule "ABC" under fasted conditions.

Treatment:

Drug: Treatment B: abiraterone acetate

Drug: Treatment C: abiraterone acetate

Drug: Treatment A: abiraterone acetate

Sequence 2: abiraterone acetate

Experimental group

Description:

Randomly assigned participants in Sequence 2 will receive different dose levels of abiraterone acetate (Treatment A = 250 mg; Treatment B = 500 mg; and Treatment C = 1000 mg) on Day 1 in each of the 3 treatment periods according to the randomized schedule "BAC" under fasted conditions.

Treatment:

Drug: Treatment B: abiraterone acetate

Drug: Treatment C: abiraterone acetate

Drug: Treatment A: abiraterone acetate

Sequence 3: abiraterone acetate

Experimental group

Description:

Randomly assigned participants in Sequence 3 will receive different dose levels of abiraterone acetate (Treatment A = 250 mg; Treatment B = 500 mg; and Treatment C = 1000 mg) on Day 1 in each of the 3 treatment periods according to the randomized schedule "CBA" under fasted conditions.

Treatment:

Drug: Treatment B: abiraterone acetate

Drug: Treatment C: abiraterone acetate

Drug: Treatment A: abiraterone acetate