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A Multiple-Dose Pharmacokinetics Study of Two Gefapixant (AF-219/MK-7264) Formulations

NCT02492776 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2022-07-22

No results posted yet for this study

Summary

The purpose of this study is to compare the multiple dose pharmacokinetics (PK) of two gefapixant (AF-219) formulations; to assess the effect of omeprazole on the multiple dose PK of two gefapixant formulations; and, to assess the safety and tolerability of gefapixant.

Conditions

  • Healthy

Interventions

DRUG

Omeprazole

20 mg oral capsules administered once daily for 8 days

DRUG

Gefapixant

Gefapixant oral tablet (25 mg administered as a divided 50 mg tablet) administered twice daily for 5 days

DRUG

Gefapixant

Gefapixant oral tablet (50 mg tablet) 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

  • Dennis Swearingen, MD · Celerion

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2015-07-07
Primary Completion
2015-08-04
Completion
2015-08-11

Countries

  • United States

Study Locations

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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 NCT02492776 on ClinicalTrials.gov