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A Study to Assess the Effect of Intragastric pH and Fasting on the Pharmacokinetics of Gefapixant (AF-219/MK-7264)

NCT02229877 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-07-22

No results posted yet for this study

Summary

The purpose of this study is to: determine the effect of stomach pH on the multiple dose pharmacokinetics (PK) of gefapixant (AF-219); assess the effect of multiple doses of gefapixant on various sensory assessments; and, assess the safety and tolerability of gefapixant.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Omeprazole

40 mg oral capsules administered twice daily for 8.5 days

DRUG

Gefapixant

Gefapixant oral tablet (25 mg administered as a divided 50 mg tablet) administered twice daily for 2 days

DRUG

Gefapixant

Gefapixant oral tablet (50 mg tablet) administered twice daily for 8 days

DRUG

Gefapixant

Gefapixant oral tablet (150 mg administered as three 50 mg tablets) administered twice daily for 8 days

Sponsors & Collaborators

  • Celerion

    collaborator INDUSTRY

  • Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

    lead INDUSTRY

Principal Investigators

  • Terry O'Reilly, M.D. · Celerion

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-06
Primary Completion
2015-05-14
Completion
2015-05-22

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02229877 on ClinicalTrials.gov