A Study to Evaluate the Relative Oral Bioavailability of Seltorexant (JNJ-42847922) After Administration of 3 Different Formulations in Healthy Participants Under Fasted and Semi-fasted Conditions
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 10/24/2018 |
Start Date: | February 9, 2018 |
End Date: | May 30, 2018 |
A Randomized, Open-label, Single-dose, 6-Period, 8-Sequence Crossover Study to Evaluate the Relative Oral Bioavailability of Seltorexant (JNJ-42847922) After Administration of 3 Different Formulations in Healthy Subjects Under Fasted and Semi-fasted Conditions
The purpose of this study is to assess and compare the pharmacokinetics (PK) and relative
oral bioavailability of 3 oral tablet formulations of seltorexant in fasted and semi-fasted
conditions.
oral bioavailability of 3 oral tablet formulations of seltorexant in fasted and semi-fasted
conditions.
Inclusion Criteria:
- Have signed an informed consent form (ICF) indicating they understand the purpose of
and procedures required for the study and are willing to participate in the study
- Willing to adhere to the prohibitions and restrictions specified in the study protocol
- If a woman of childbearing potential, must have a negative serum beta-human chorionic
gonadotropin (beta-hCG) pregnancy test at screening and a negative urine pregnancy
test on Day -1 of the first treatment period
- If a woman, must agree not to donate eggs (ova, oocytes) for the purposes of assisted
reproduction during the study and for at least 30 days after the last study drug
administration
- A man, who is sexually active with a woman of childbearing potential and has not had a
vasectomy, must agree to use an adequate contraception method as deemed appropriate by
the investigator (example, vasectomy, double-barrier, partner using effective
contraception) and to not donate sperm during the study and for 3 months after
receiving the last dose of study drug
Exclusion Criteria:
- Has a 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 (Child-Pugh Score greater than or equal to [>=] 7)
or renal insufficiency (estimated glomerular filtration rate [eGFR] less than (<) 60
milliliter per minute per 1.73 meter square (mL/min/1.73m^2) based on the modified
diet renal disease [MDRD] formula determined at screening, thyroid disease, neurologic
(including seizure disorders) 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. Significant gastrointestinal past
history, or any disease/surgery (excluding cholecystectomy and appendectomy) that
would interfere with drug absorption
- Has clinically significant abnormal values for hematology, serum chemistry (including
thyroid stimulating hormone [TSH] at screening only) or urinalysis at screening or at
admission to the study site. It is expected that laboratory values will generally be
within the normal range for the laboratory, though minor deviations, which are not
considered to be of clinical significance to both the investigator and to the Janssen
Research & Development Safety Physician, are acceptable
- Has clinically significant abnormal physical examination, vital signs, or 12 lead
electrocardiogram (ECG) at screening or at admission to the study site as deemed
appropriate by the investigator
- Has used any prescription or nonprescription medication (including vitamins and herbal
supplements), except for paracetamol (acetaminophen), oral contraceptives, and
hormonal replacement therapy within 14 days before the first dose of the study drug is
scheduled or has used any systemic herbal medications or dietary supplements including
products containing Hypericum perforatum (example, St. John's Wort) from 21 days
before the first dose of study drug is scheduled
- Received a known inhibitor of CYP(cytochrome P450)3A4 or CYP2C9 activity within 14
days or a period less than 5 times the drugs half-life; whichever is longer, before
the first dose of the study drug is scheduled
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