Bioavailability Study of 3 Tablet Formulations vs. Capsule Formulation of JNJ-56021927 in Fasting Healthy Male Participants
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 2/7/2015 |
Start Date: | June 2014 |
End Date: | September 2014 |
Contact: | This study is not yet recruiting patients. Please check back for future recruiting sites, or email |
Email: | JNJ.CT@sylogent.com |
A Single-Dose, Open-Label, Randomized, Parallel-Group Study to Assess the Relative Bioavailability of 3 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 (PK - the study of the way a
drug enters and leaves the blood and tissues over time) and relative bioavailability (the
extent to which a drug or other substance becomes available to the body) of JNJ-56021927,
when administered as 3 tablet formulations (test) compared with JNJ-54781532 softgel capsule
formulation (reference) in healthy male participants under fasted conditions at a single
dose of 240 milligram (mg).
drug enters and leaves the blood and tissues over time) and relative bioavailability (the
extent to which a drug or other substance becomes available to the body) of JNJ-56021927,
when administered as 3 tablet formulations (test) compared with JNJ-54781532 softgel capsule
formulation (reference) in healthy male participants under fasted conditions at a single
dose of 240 milligram (mg).
This is a randomized (study medication assigned to participants by chance), open-label (all
people know the identity of the intervention), single-center, 4-treatment, parallel design
(a medical research study comparing the response in two or more groups of participants
receiving different interventions) study of a single dose of 240 mg JNJ-56021927. The
duration of study will be approximately of 78 days per participant. The study consists of 3
parts: Screening phase (that is, 21 days before study commences on Day 1); Open-label
Treatment phase (consists of 4 parallel single-dose treatments); and End-of-Study
(completion of the Hour 1344 PK sampling on Day 57, or upon early withdrawal). All the
eligible participants will be randomly assigned to 1 of the 4 possible treatments: Treatment
A (240 mg dose as softgel capsule); Treatment B (240 mg dose as Tablet Formulation 1);
Treatment C (240 mg dose as Tablet Formulation 2); or Treatment D (240 mg dose as Tablet
Formulation 3). Participants will fast overnight from food and fluids (excluding
non-carbonated water) for at least 10 hours before study drug administration on Day 1. Blood
samples will be collected pre-dose and over 1,344 hours (Day 57) after dosing
for the determination of JNJ-56021927 concentration and its active metabolite. Relative
bioavailability of 3 tablet formulations as compared to the softgel capsule formulation of
JNJ-56021927 will be evaluated primarily. Participants' safety will be monitored throughout
the study.
people know the identity of the intervention), single-center, 4-treatment, parallel design
(a medical research study comparing the response in two or more groups of participants
receiving different interventions) study of a single dose of 240 mg JNJ-56021927. The
duration of study will be approximately of 78 days per participant. The study consists of 3
parts: Screening phase (that is, 21 days before study commences on Day 1); Open-label
Treatment phase (consists of 4 parallel single-dose treatments); and End-of-Study
(completion of the Hour 1344 PK sampling on Day 57, or upon early withdrawal). All the
eligible participants will be randomly assigned to 1 of the 4 possible treatments: Treatment
A (240 mg dose as softgel capsule); Treatment B (240 mg dose as Tablet Formulation 1);
Treatment C (240 mg dose as Tablet Formulation 2); or Treatment D (240 mg dose as Tablet
Formulation 3). Participants will fast overnight from food and fluids (excluding
non-carbonated water) for at least 10 hours before study drug administration on Day 1. Blood
samples will be collected pre-dose and over 1,344 hours (Day 57) after dosing
for the determination of JNJ-56021927 concentration and its active metabolite. Relative
bioavailability of 3 tablet formulations as compared to the softgel capsule formulation of
JNJ-56021927 will be evaluated primarily. Participants' safety will be monitored throughout
the study.
Inclusion Criteria:
- Must agree to use an adequate contraception method as deemed appropriate by the
investigator, 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, including pulse rate between 45 and 99 beats per minute (bpm), QT corrected
Fridericia (QTcF) interval less than or equal to 450 milliseconds (msec), QRS
interval of less than 120 msec, PR interval less than 220 msec, morphology
consistent with healthy cardiac conduction and function
- Nonsmoker within the previous 2 months
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, hepatic or renal insufficiency, thyroid disease,
neurologic or psychiatric disease, infection
- Known hypersensitivity to Vitamin E
- History of stomach or intestinal surgery or resection that would
potentially alter absorption or excretion of orally administered drugs
- Known allergy to the study drug or any of the excipients of the formulation
- Unable to swallow solid, oral dosage forms whole with the aid of water
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