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NCT01216046 · ClinicalTrials.gov registry record · Phase 1
Drug-Drug Interaction Study of VX-770 and VX-809 in Healthy Subjects
A Phase 1 study of Cystic Fibrosis, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT01216046: Completed Phase 1 study of Cystic Fibrosis, sponsored by Vertex Pharmaceuticals Incorporated.
NCT01216046 is a Phase 1 study of Cystic Fibrosis that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 48 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01216046, a Phase 1 study of Cystic Fibrosis, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to assess the pharmacokinetics and safety of VX-809 and VX-770 alone and in combination in healthy subjects.
Primary Outcome
Blood samples drawn during the study will be analyzed to measure the PK parameters, such as concentration, exposure and half-life of VX-809 and its metabolite.
Conditions Studied
Interventions
- DRUG VX-809
- DRUG VX-770
- DRUG VX-809 placebo
- DRUG VX-770 placebo
Study Locations (1)
Kansas
- PRA - Lenexa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2010-10 |
| Est. Completion | 2011-05 |
| Phase | Phase 1 |
What the finished NCT01216046 record still lists
NCT01216046 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 4 interventions - of which VX-809 is the first listed.
NCT01216046 reports a single indexed study location in Kansas.
Frequently Asked Questions
What is clinical trial NCT01216046 about?
NCT01216046 is a clinical study titled "Drug-Drug Interaction Study of VX-770 and VX-809 in Healthy Subjects". The purpose of this study is to assess the pharmacokinetics and safety of VX-809 and VX-770 alone and in combination in healthy subjects.
What is the current status of trial NCT01216046?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2010-10. Estimated completion is 2011-05.
What conditions does trial NCT01216046 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
What interventions are being tested in trial NCT01216046?
The interventions under investigation include: VX-809 (DRUG), VX-770 (DRUG), VX-809 placebo (DRUG), VX-770 placebo (DRUG).
Who is sponsoring clinical trial NCT01216046?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01216046 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cystic Fibrosis
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 NCT01216046's enrollment target sits among peer trials
48 92nd of 169 higher than 78 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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