A Study to Investigate the Effect of Increased Gastric pH on the Oral Bioavailability of the Orexin-2 Receptor Antagonist JNJ-42847922 in Healthy Participants
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 4/21/2016 |
Start Date: | June 2015 |
End Date: | July 2015 |
A Study to Investigate the Effect of Increased Gastric pH From the Administration of the Proton Pump Inhibitor (PPI) Rabeprazole on the Oral Bioavailability of the Orexin-2 Receptor Antagonist JNJ-42847922 in Healthy Subjects
The purpose of this study is to assess the effects of daily administration of rabeprazole on
the single-dose pharmacokinetics of JNJ-42847922 in healthy participants.
the single-dose pharmacokinetics of JNJ-42847922 in healthy participants.
This is an open-label, single-center, fixed-sequence study designed to assess the effects of
multiple oral administration of rabeprazole (a PPI) on the pharmacokinetics of a single oral
dose of JNJ-42847922 in healthy participants. The study consists of 3 phases: a Screening
Phase of approximately 4 weeks (Days -29 to -2); an Open Label Treatment Phase (Days -1 to
7); and an End-of-Study Phase occurring from 7 to 14 days after the last dose of study drug.
All participants will receive JNJ-42847922, orally on Day 1 (alone) and Day 6 (along with
rabeprazole).Rabeprazole will be administered orally on Day 2 to Day 6. Pharmacokinetics
will primarily be for JNJ-42847922, M12 metabolite and M16 metabolite. Participant's safety
will be monitored throughout the study.
multiple oral administration of rabeprazole (a PPI) on the pharmacokinetics of a single oral
dose of JNJ-42847922 in healthy participants. The study consists of 3 phases: a Screening
Phase of approximately 4 weeks (Days -29 to -2); an Open Label Treatment Phase (Days -1 to
7); and an End-of-Study Phase occurring from 7 to 14 days after the last dose of study drug.
All participants will receive JNJ-42847922, orally on Day 1 (alone) and Day 6 (along with
rabeprazole).Rabeprazole will be administered orally on Day 2 to Day 6. Pharmacokinetics
will primarily be for JNJ-42847922, M12 metabolite and M16 metabolite. Participant's safety
will be monitored throughout the study.
Inclusion Criteria:
- If a woman, must be postmenopausal (no spontaneous menses for at least 2 years) or
surgically sterile (including but not limited to hysterectomy, oophorectomy,
salpingectomy, tubal ligation, and tubal occlusion). Women must agree to not donate
eggs (ova, oocytes) during the study and for 3 months after the last dose of study
drug. Women of child-bearing potential or currently breastfeeding a child are not
allowed to participate in the study
- If a man, must agree to use an adequate contraception method as deemed appropriate by
the investigator (e.g., 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
- Body mass index (BMI) (weight [kilogram {kg}/height^2 [meter]^2) between 18 and 30
kg/m^2 (inclusive), and body weight not less than 50 kg
- Blood pressure (after the participant is supine for 5 minutes) between 90 and 140
millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg
diastolic
- A participants must be a non-smoker
Exclusion Criteria:
- Current or history of gastrointestinal disorder
- 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 disease,
infection, hypertension or vascular disorders, kidney or urinary tract disturbances,
significant psychiatric disorder (history of or current diagnosis), history of
epilepsy or fits of unexplained black-outs, 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,
urinalysis, or thyroid stimulating hormone (TSH) at screening or at admission to the
study center (Day -1) as deemed appropriate by the investigator
- Clinically significant abnormal physical examination, vital signs, or 12-lead
electrocardiogram (ECG) at screening or at admission to the study center (Day -1) as
deemed appropriate by the investigator
- Use of any prescription or nonprescription medication, within 7 days before the first
scheduled dose of the study drug (including vitamins and herbal supplements), except
acetaminophen and hormonal replacement therapy
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