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NCT02492776 · ClinicalTrials.gov registry record · Phase 1
A Multiple-Dose Pharmacokinetics Study of Two Gefapixant (AF-219/MK-7264) Formulations
A Phase 1 study of Healthy, sponsored by Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT02492776: Completed Phase 1 study of Healthy, sponsored by Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
NCT02492776 is a Phase 1 study of Healthy that has completed, run by Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). The registered enrollment target is 14 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02492776, a Phase 1 study of Healthy, has completed, sponsored by Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Plasma gefapixant concentration versus time profiles will be plotted for each subject; similar summary plots will be constructed for each treatment period. Plasma gefapixant PK parameters will be calculated using noncompartmental methods and summarized using descriptive statistics by each treatment.
Conditions Studied
Interventions
- DRUG Omeprazole
- DRUG Gefapixant
Study Locations (1)
Arizona
- Celerion - Tempe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2015-07-07 |
| Est. Completion | 2015-08-11 |
| Phase | Phase 1 |
Sponsor
Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)6 total trials
What the finished NCT02492776 record still lists
NCT02492776 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Omeprazole is the first listed.
NCT02492776 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT02492776 about?
NCT02492776 is a clinical study titled "A Multiple-Dose Pharmacokinetics Study of Two Gefapixant (AF-219/MK-7264) Formulations". 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.
What is the current status of trial NCT02492776?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2015-07-07. Estimated completion is 2015-08-11.
What conditions does trial NCT02492776 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT02492776?
The interventions under investigation include: Omeprazole (DRUG), Gefapixant (DRUG).
Who is sponsoring clinical trial NCT02492776?
This trial is sponsored by Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02492776 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02492776's enrollment target sits among peer trials
14 974th of 1090 higher than 106 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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