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

NCT02790840 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2017-04-18

No results posted yet for this study

Summary

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

Conditions

  • Healthy

Interventions

DRUG

Omeprazole

20 mg oral capsules administered once daily for 10 days

DRUG

Omeprazole

40 mg oral capsules administered twice daily for 10 days

DRUG

Gefapixant

Gefapixant oral tablets (15 mg administered as two 7.5 mg tablets) administered twice daily for 15 days

DRUG

Gefapixant

Gefapixant oral tablets (30 mg administered as four 7.5 mg tablets) administered twice daily for 15 days

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Danielle Armas, 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
2016-05-16
Primary Completion
2016-06-15
Completion
2016-06-21

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 NCT02790840 on ClinicalTrials.gov