A Study of Seltorexant (JNJ-42847922) After Single-Dose Administration in Healthy Participants



Status:Recruiting
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:3/13/2019
Start Date:October 1, 2018
End Date:May 3, 2019
Contact:Study Contact
Email:JNJ.CT@sylogent.com
Phone:844-434-4210

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An Open-Label, Randomized, Multi-panel, Crossover Study to Evaluate the Relative Oral Bioavailability and Food Effect of Seltorexant (JNJ-42847922) After Single-Dose Administration in Healthy Subjects

The purpose of this study is to compare the rate and extent of absorption (relative
bioavailability) of seltorexant Phase 3 test formulation(s) relative to a reference Phase 2b
tablet formulation dosed in the evening under fasted and semi-fasted conditions (3 hours
after meal) and to assess the effect of a high-fat/high-calorie meal, timing of the meal on
the rate and extent of absorption of seltorexant in healthy male and female participants.


Inclusion Criteria:

- Be healthy on the basis of medical history (screening only), physical examination,
vital signs, and 12-lead electrocardiogram (ECG) performed at screening and Day 1
(predose)

- Be healthy on the basis of clinical laboratory tests performed at screening. If the
results of the serum chemistry panel, hematology, or urinalysis are outside the normal
reference ranges, the participant may be included only if the investigator judges the
abnormalities or deviations from normal to be not clinically significant. This
determination must be recorded in the participant's source documents and initialed by
the investigator

- All female participants (regardless 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 each treatment period

- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted
reproduction during the study and for at least 1 month 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 (for example, abstinence, vasectomy, barrier method, partner using
effective contraception)

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 (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 at screening only), thyroid disease, neurologic
(including seizure disorders) or psychiatric disease (depression or anxiety disorder
in remission is acceptable), 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 past gastrointestinal medical
history, or any disease/surgery that would with interfere drug absorption

- Clinically significant abnormal values for hematology, clinical 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 the investigator, are acceptable

- Clinically significant abnormal physical examination, vital signs, or 12-lead ECG at
screening or at admission to the study site though minor deviations, which are not
considered to be of clinical significance to the investigator are acceptable

- Use of any prescription or nonprescription medication (including vitamins and herbal
supplements), except for 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 (for example, St. John's Wort) from 21 days before the
first dose of study drug is scheduled

- Received a known inhibitor of Cytochrome P450 3A4 (CYP3A4) 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
We found this trial at
1
site
3838 South 700 East
Salt Lake City, Utah 84124
?
mi
from
Salt Lake City, UT
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