A Study to Assess the Relative Bioavailability of 7 Test Tablet Formulations of JNJ-56021927 With Respect to the Capsule Formulation of JNJ-56021927 in Healthy Male Participants
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 5/5/2014 |
Start Date: | December 2013 |
End Date: | April 2014 |
Email: | JNJ.CT@sylogent.com |
A Single-Dose, Open-Label, Randomized, Parallel-Group Study to Assess the Relative Bioavailability of 7 Test Tablet Formulations of JNJ-56021927 With Respect to the Capsule Formulation of JNJ-56021927 Under Fasted Conditions in Healthy Male Subjects
The purpose of this study is to evaluate the pharmacokinetics (what the body does to the
medication) and relative bioavailability (the extent to which a medication or other
substance becomes available to the body) of JNJ-56021927 when administered as 7 test tablet
formulations of JNJ-56021927 compared with the softgel capsule formulation of JNJ-56021927
in healthy male participants under fasted conditions at a single dose of 240 mg.
medication) and relative bioavailability (the extent to which a medication or other
substance becomes available to the body) of JNJ-56021927 when administered as 7 test tablet
formulations of JNJ-56021927 compared with the softgel capsule formulation of JNJ-56021927
in healthy male participants under fasted conditions at a single dose of 240 mg.
This is a randomized (the study medication is assigned by chance), open-label (all people
know the identity of the intervention), single-center, 8-treatment, parallel-group (each
group of participants will be treated at the same time) study. Approximately 120
participants (15 participants in each treatment group) will participate in this study. All
participants will be randomly assigned to 1 of 8 possible treatments (A, B, C, D, E, F, G,
and H). The study will consist of a screening phase (within 21 days before the first
administration of the study medication), a treatment phase with 8 parallel single-dose
treatments (8 days); a follow up phase (42 days) and an end-of-study or early withdrawal
assessments (Day 57). Safety will be evaluated by the assessment of adverse events, clinical
laboratory tests, vital signs, and physical examination which will be monitored throughout
the study. The duration of participation in the study for an individual participant will be
approximately 78 days.
know the identity of the intervention), single-center, 8-treatment, parallel-group (each
group of participants will be treated at the same time) study. Approximately 120
participants (15 participants in each treatment group) will participate in this study. All
participants will be randomly assigned to 1 of 8 possible treatments (A, B, C, D, E, F, G,
and H). The study will consist of a screening phase (within 21 days before the first
administration of the study medication), a treatment phase with 8 parallel single-dose
treatments (8 days); a follow up phase (42 days) and an end-of-study or early withdrawal
assessments (Day 57). Safety will be evaluated by the assessment of adverse events, clinical
laboratory tests, vital signs, and physical examination which will be monitored throughout
the study. The duration of participation in the study for an individual participant will be
approximately 78 days.
Inclusion Criteria:
- During the study and for 3 months after receiving study medication, must agree to use
an adequate contraception method (eg, vasectomy, double-barrier, partner using
effective contraception), always use a condom during sexual intercourse and to not
donate sperm
- Body mass index (weight [kg]/height [m]2) between 18 and 30 kg/m2 and body weight not
less than 50 kg
- Blood pressure (after the participant is supine for 5 minutes) between 90 and 140
mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
- A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and
function
- Non-smoker for 2 months prior to study participation
Exclusion Criteria:
- History of or current clinically significant medical illness including cardiac
arrhythmias or other cardiac disease, hematologic disease, coagulation disorders,
lipid abnormalities, significant pulmonary disease (including bronchospastic
respiratory disease), diabetes mellitus, renal or hepatic insufficiency, thyroid
disease, neurologic or psychiatric disease, and infection
- Clinically significant abnormal values for hematology, clinical chemistry or
urinalysis, physical examination, vital signs or 12-lead ECG at screening or at
admission to the study center as deemed appropriate by the investigator
- Presence of sexual dysfunction (eg, abnormal libido or erectile dysfunction) or any
medical condition that would affect sexual function
- Use of any prescription or nonprescription medication (including vitamins and herbal
supplements), except for acetaminophen within 14 days before the first dose of the
study drug is scheduled
- History of clinically significant allergies or known hypersensitivity to vitamin E
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