Study to Assess Drug-Drug Interaction Between Itraconazole or Gemfibrozil and JNJ-56021927
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 2/7/2015 |
Start Date: | September 2014 |
End Date: | November 2014 |
Email: | JNJ.CT@sylogent.com |
An Open-Label, Randomized, Parallel-Group Drug-Drug Interaction Study to Assess the Effect of Multiple Doses of Itraconazole or Gemfibrozil on the Pharmacokinetics of a Single Dose of JNJ-56021927 in Healthy Male Subjects
The purpose of this study is to assess the effect of multiple doses of itraconazole or
gemfibrozil on the pharmacokinetics (the study of the way a drug enters and leaves the blood
and tissues over time) of JNJ-56021927 and its metabolites (JNJ 56142060 and JNJ-56142021)
in healthy male participants.
gemfibrozil on the pharmacokinetics (the study of the way a drug enters and leaves the blood
and tissues over time) of JNJ-56021927 and its metabolites (JNJ 56142060 and JNJ-56142021)
in healthy male participants.
This is a single-dose, single-center, open-label (all people know the identity of the
intervention), 3-treatment, randomized (study medication assigned to participants by chance)
and parallel-group (a medical research study comparing the response in two or more groups of
participants receiving different interventions [treatments]) study. The study consists of
Screening Phase (that is, 21 days before study commences on Day 1); open-label treatment
Phase and end-of-study or early withdrawal assessment. All participants will be randomly
assigned to 1 of 3 treatments, that is, Treatment A (single dose of JNJ-56021927 on Day 1),
Treatment B (200 milligram [mg] itraconazole once daily from Day 1 up to Day 32 along with
single dose of JNJ-56021927 on Day 4), and Treatment C (600 mg gemfibrozil twice daily from
Day 1 up to Day 32 along with single dose of JNJ-56021927 on Day 4). Blood samples will be
collected for evaluation of pharmacokinetics at pre-dose and post-dose of study treatment.
The maximum duration of participation in the study per participant will be approximately 78
days (Treatment A) or 81 days (Treatment B and C). Participants' safety will be monitored
throughout the study.
intervention), 3-treatment, randomized (study medication assigned to participants by chance)
and parallel-group (a medical research study comparing the response in two or more groups of
participants receiving different interventions [treatments]) study. The study consists of
Screening Phase (that is, 21 days before study commences on Day 1); open-label treatment
Phase and end-of-study or early withdrawal assessment. All participants will be randomly
assigned to 1 of 3 treatments, that is, Treatment A (single dose of JNJ-56021927 on Day 1),
Treatment B (200 milligram [mg] itraconazole once daily from Day 1 up to Day 32 along with
single dose of JNJ-56021927 on Day 4), and Treatment C (600 mg gemfibrozil twice daily from
Day 1 up to Day 32 along with single dose of JNJ-56021927 on Day 4). Blood samples will be
collected for evaluation of pharmacokinetics at pre-dose and post-dose of study treatment.
The maximum duration of participation in the study per participant will be approximately 78
days (Treatment A) or 81 days (Treatment B and C). Participants' safety will be monitored
throughout the study.
Inclusion Criteria:
- Must agree to use an adequate contraception method as deemed appropriate by the
Investigator and specified in protocol, always use a condom during sexual
intercourse, and to not donate sperm during the study and for 3 months after
receiving the study drug
- Body mass index between 18 and 30 kilogram (kg) per square meter, and body weight not
less than 50 kg
- Blood pressure (supine for 5 minutes) between 90 and 140 millimeter of mercury (mm
Hg) systolic, and no higher than 90 mm Hg diastolic
- A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and
function at Screening, including: Pulse rate between 45 and 99 beats per minute
(bpm); QTc interval less than or equal to (<=) 450 milliseconds; QRS interval of less
than (<) 120 milliseconds; PR interval <220 milliseconds; and morphology consistent
with healthy cardiac conduction and function
- Nonsmoker within the previous 2 months (calculated from first dosing)
Exclusion Criteria:
- History of or current clinically significant medical illness including (but not
limited to) cardiac arrhythmias or other cardiac disease, hematologic disease,
coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid
abnormalities, significant pulmonary disease, including bronchospastic respiratory
disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease,
neurologic or psychiatric disease, infection, or any other illness that the
Investigator considers should exclude the participant or that could interfere with
the interpretation of the study results
- 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
- Medical history of gallbladder disease (cholecystitis, cholelithiasis,
cholecystectomy)
- Presence of sexual dysfunction or any medical condition that would affect sexual
function
- Screening serum testosterone level of < 200 nanogram/deciliter (ng/dL)
- Previous history of photoallergy or phototoxic reaction during treatment with
fibrates
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