Healthy Volunteers
Conditions
Keywords
Healthy volunteers, Drug-drug Interaction, Pharmacokinetics, Abiraterone, JNJ-589485, Abiraterone acetate, JNJ-212082, Pioglitazone HCl
Brief summary
The purpose of this study is to evaluate the effects of abiraterone on the pharmacokinetics (study of what the body does to a drug) of pioglitazone when coadministered with abiraterone acetate in healthy adult male participants.
Detailed description
This is an open-label (identity of assigned study drug will be known) single-dose drug-drug interaction study to assess the effect of abiraterone on pioglitazone. Approximately 16 healthy adult male participants will be enrolled in this study. The study consists of a screening phase, an open-label treatment phase consisting of 2 single-dose treatment periods, end-of-study or withdrawal assessments done upon completion of the 72-hour pharmacokinetic sampling on Day 11 of Period 2 or upon withdrawal, and a follow-up visit 5 to 7 days after the last study procedure. The total study length is 32 days. Participants will receive pioglitazone alone on Day 1 (Period 1) of the study. On Day 8 (Period 2), participants will receive a single dose of abiraterone acetate followed by a single dose of pioglitazone one hour later. Successive pioglitazone administrations will be separated by a washout period of 7 days. Participants will be confined to the study center from Day -1 to Day 4 of Period 1 and from Day 7 to Day 11 of Period 2, at least 10 hours before each study drug administration until completion of the 72-hour blood sample collection for each period. A pharmacogenomic blood sample will be collected from all participants on Day -1. Safety will be monitored throughout the study.
Interventions
DRUGAbiraterone acetate
1000 mg tablets administered by mouth on Day 8
DRUGPioglitazone HCl
15 mg tablet administered by mouth on Day 1, and Day 8 1 hour after study drug administration
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Agrees to protocol-defined use of effective contraception for 1 week after receiving the last dose of study drug * Agrees to not donate sperm during the study and for 1 week after receiving the last dose of study drug * Body mass index between 18 and 30 kg/m2 and body weight not less than 50 kg * Blood pressure between 90 and 140 mmHg systolic, and no higher than 90 mmHg diastolic * A 12-lead electrocardiogram consistent with normal cardiac conduction and function * Non-smoker * Laboratory values within protocol -defined parameters
Exclusion criteria
* History of or current clinically significant medical illness * Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or at admission to the study center as deemed appropriate by the investigator * Presence of sexual dysfunction or any medical condition that would affect sexual function * Clinically significant abnormal physical examination, vital signs, or 12-lead electrocardiogram * Use of any prescription or nonprescription medication (including vitamins and herbal supplements) before the first dose of the study drug is scheduled through study completion * History of drug or alcohol abuse within 3 years before screening or positive test result(s) for alcohol and/or drugs of abuse at screening and Day -1 and at Day 7 of the treatment period * Known allergy to the study drug or any of the excipients of the formulation * History of stomach or intestinal surgery or resection that would potentially alter absorption or excretion of orally administered drugs (appendectomy and hernia repair will be allowed) * Donated blood or blood products or had substantial loss of blood within 3 months before the first administration of study drug or intention to donate blood or blood products during the study * Received an experimental drug or used an experimental medical device within 1 month or within a period less than 10 times the drug's half-life, whichever is longer, before the first dose of the study drug is scheduled * Positive test for human immunodeficiency virus 1 and 2 antibodies, hepatitis B surface antigen, hepatitis B core antibody or hepatitis C antibodies * Preplanned surgery or procedures that would interfere with the conduct of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed plasma concentration of pioglitazone | Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h |
| Time to reach the maximum observed plasma concentration of pioglitazone | Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h |
| Area under the plasma concentration-time curve from time 0 to time of the last observed quantifiable concentration of pioglitazone | Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h |
| Area under the plasma concentration-time curve from time 0 to infinite time of pioglitazone | Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h |
| Percentage of area under the plasma concentration time curve obtained by extrapolation of pioglitazone | Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h |
| Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of pioglitazone | Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h |
| Time to last observed quantifiable plasma concentration of pioglitazone | Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h |
Secondary
| Measure | Time frame |
|---|---|
| Apparent total plasma clearance of drug after extravascular administration of pioglitazone | Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h |
| Metabolite to parent drug ratio for maximum observed plasma concentration | Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h |
| Maximum observed plasma concentration of abiraterone | Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h |
| Metabolite to parent drug ratio for area under the plasma concentration time curve from time 0 to infinite time | Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h |
| Number of participants affected by adverse events by MedDRA system organ class (SOC) and Preferred term (PT) | Up to 30 days after the last dose of study medication |
| Metabolite to parent drug ratio for area under the plasma concentration time curve from time 0 to time of the last observed quantifiable concentration | Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h |
| Time to reach the maximum observed plasma concentration of abiraterone | Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h |
| Area under the plasma concentration-time curve from time 0 to time of the last observed quantifiable concentration of abiraterone | Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h |
| Area under the plasma concentration-time curve from time 0 to infinite time of abiraterone | Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h |
| Percentage of area under the plasma concentration-time curve obtained by extrapolation of abiraterone | Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h |
| Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of abiraterone | Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h |
| Time to last observed quantifiable plasma concentration of abiraterone | Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h |
Countries
Belgium
Outcome results
None listed