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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

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ClinicalTrials.gov Identifier: NCT02475161
Recruitment Status : Completed
First Posted : June 18, 2015
Last Update Posted : January 11, 2016
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: JNJ-42847922 Drug: Rabeprazole Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: JNJ-42847922 Plus Rabeprazole
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
JNJ-42847922 will be administered as 20 mg tablet orally.

Drug: Rabeprazole
Rabeprazole will be administered as 20 mg tablet orally.




Primary Outcome Measures :
  1. Area Under the Plasma Concentration-Time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC [0-last]) of JNJ-42847922 [ Time Frame: 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 0 to the last quantifiable concentration of JNJ-42847922 will be reported.

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

  3. Maximum Observed Plasma Concentration (Cmax) of JNJ-42847922 [ Time Frame: 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 ]
    The Cmax is the maximum observed plasma concentration.


Secondary Outcome Measures :
  1. Area Under the Plasma Concentration-Time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC [0-last]) of M12 and M16 [ Time Frame: 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 0 to the last quantifiable concentration of M12 and M16.

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

  3. Maximum Observed Plasma Concentration (Cmax) of M12 and M16 [ Time Frame: 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 ]
    The Cmax is the maximum observed plasma concentration.

  4. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 7 to 14 days after last dose of study drug or early withdrawal) ]
    An AE was any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02475161


Locations
United States, Kansas
Overland Park, Kansas, United States
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02475161     History of Changes
Other Study ID Numbers: CR107627
42847922EDI1006 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: June 18, 2015    Key Record Dates
Last Update Posted: January 11, 2016
Last Verified: January 2016

Keywords provided by Janssen Research & Development, LLC:
Healthy
Rabeprazole
JNJ-42847922

Additional relevant MeSH terms:
Rabeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action