Expired Study
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Overland Park, Kansas


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

CR107627


NCT ID:

NCT02475161


Secondary ID:

42847922EDI1006


Study Acronym:


Brief Title:

A Study to Investigate the Effect of Increased Gastric pH on the Oral Bioavailability of the Orexin-2 Receptor Antagonist JNJ-42847922 in Healthy Part


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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Janssen Research & Development, LLC


Oversight Authority:

  • United States: Food and Drug Administration
  • United States: U.S. Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Pharmacokinetics Study, I


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

16


Enrollment Type:

Actual


Overall Contact Information

Official Name:Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC

Study Dates

Start Date:June 2015
Completion Date:July 2015
Completion Type:Actual
Primary Completion Date:July 2015
Primary Completion Type:Actual
Verification Date:January 2016
Last Changed Date:January 8, 2016
First Received Date:June 16, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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)
Safety Issues:True
Description: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 resultin
Outcome Type:Secondary Outcome
Measure: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 admi
Safety Issues:False
Description:The Cmax is the maximum observed plasma concentration.
Outcome Type:Secondary Outcome
Measure: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 admi
Safety Issues:False
Description: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 las
Outcome Type:Secondary Outcome
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
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 admi
Safety Issues:False
Description:Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration of M12 and M16.
Outcome Type:Primary Outcome
Measure: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 admi
Safety Issues:False
Description:The Cmax is the maximum observed plasma concentration.
Outcome Type:Primary Outcome
Measure: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 admi
Safety Issues:False
Description: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 las
Outcome Type:Primary Outcome
Measure: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 admi
Safety Issues:False
Description:Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration of JNJ-42847922 will be reported.

Study Interventions

Intervention Type:Drug
Name:JNJ-42847922
Description:JNJ-42847922 will be administered as 20 mg tablet orally.
Arm Name:JNJ-42847922 Plus Rabeprazole
Intervention Type:Drug
Name:Rabeprazole
Description:Rabeprazole will be administered as 20 mg tablet orally.
Arm Name:JNJ-42847922 Plus Rabeprazole

Study Arms

Study Arm Type:Experimental
Arm Name:JNJ-42847922 Plus Rabeprazole
Description: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.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Janssen Research & Development, LLC

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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