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

NCT02475161 | Completed Phase 1

• 2 other identifiers: CR10762742847922EDI1006
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Healthy; Rabeprazole; JNJ-42847922

Outcome Measures

Primary Outcomes (3)

• Area Under the Plasma Concentration-Time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC [0-last]) of JNJ-42847922

  Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration of JNJ-42847922 will be reported.

  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

• Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of JNJ-42847922

  The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.

  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

• Maximum Observed Plasma Concentration (Cmax) of JNJ-42847922

  The Cmax is the maximum observed plasma concentration.

  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 (4)

• Area Under the Plasma Concentration-Time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC [0-last]) of M12 and M16

  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

• Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of M12 and M16

  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

• Maximum Observed Plasma Concentration (Cmax) of M12 and M16

  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

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  7 to 14 days after last dose of study drug or early withdrawal)

Study Arms (1)

JNJ-42847922 Plus Rabeprazole

EXPERIMENTAL

Participants will receive JNJ-42847922, 20 milligram (mg) on Day 1 and Day 6. Participants will receive rabeprazole 20 mg once daily from Day 2 to Day 6.

Drug: JNJ-42847922; Drug: Rabeprazole

Interventions

JNJ-42847922 DRUG

JNJ-42847922 will be administered as 20 mg tablet orally.

JNJ-42847922 Plus Rabeprazole

Rabeprazole DRUG

Rabeprazole will be administered as 20 mg tablet orally.

JNJ-42847922 Plus Rabeprazole

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Overland Park, Kansas, United States

Location

MeSH Terms

Interventions

seltorexant; Rabeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2015
• First Posted: June 18, 2015
• Study Start: June 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: February 3, 2025

Record last verified: 2025-01

Locations

US (1)