Clinical trial NCT02475161: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy
Rabeprazole
JNJ-42847922
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2015-06-18
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Area Under the Plasma Concentration-Time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC [0-last]) of JNJ-42847922
timeFrame: Pre-dose; 10, 20, 30, 45 minutes; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 hours after study drug administration on Day 1 and Day 6
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of JNJ-42847922
timeFrame: Pre-dose; 10, 20, 30, 45 minutes; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 hours after study drug administration on Day 1 and Day 6
measure: Maximum Observed Plasma Concentration (Cmax) of JNJ-42847922
timeFrame: Pre-dose; 10, 20, 30, 45 minutes; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 hours after study drug administration on Day 1 and Day 6
Secondary outcomes:
measure: Area Under the Plasma Concentration-Time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC [0-last]) of M12 and M16
timeFrame: Pre-dose; 10, 20, 30, 45 minutes; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 hours after study drug administration on Day 1 and Day 6
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of M12 and M16
timeFrame: Pre-dose; 10, 20, 30, 45 minutes; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 hours after study drug administration on Day 1 and Day 6
measure: Maximum Observed Plasma Concentration (Cmax) of M12 and M16
timeFrame: Pre-dose; 10, 20, 30, 45 minutes; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 hours after study drug administration on Day 1 and Day 6
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: 7 to 14 days after last dose of study drug or early withdrawal)
Other outcomes:
Locations:
city: Overland Park
country: United States
state: Kansas
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: