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NCT01637922 · ClinicalTrials.gov registry record · Phase 1
Drug Interaction Study With BI 201335 and Methadone or Buprenorphine/Naloxone
A Phase 1 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT01637922: Completed Phase 1 study, sponsored by Boehringer Ingelheim.
NCT01637922 is a Phase 1 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 34 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01637922, a Phase 1 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
Study Summary
Otherwise healthy subjects who are currently bein maintained on either methadone or buprenorphine/naloxone for opioid maintenance therapy who have been on a stable dose for at least 30 days will be administered BI 201335 daily to determine if a drug interaction occurs between BI 201335 and either methadone or buprenorphine/naloxone.
Primary Outcome
These are the unadjusted summary statistics on the original scale for area under the concentration time curve (AUC) of faldaprevir in plasma over a uniform dosing interval from 0 to 24 hours.
Interventions
- DRUG BI 201335
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2012-08 |
| Est. Completion | 2012-11 |
| Phase | Phase 1 |
What the finished NCT01637922 record still lists
NCT01637922 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 1 intervention - of which BI 201335 is the first listed.
NCT01637922 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01637922 about?
NCT01637922 is a clinical study titled "Drug Interaction Study With BI 201335 and Methadone or Buprenorphine/Naloxone". Otherwise healthy subjects who are currently bein maintained on either methadone or buprenorphine/naloxone for opioid maintenance therapy who have been on a stable dose for at least 30 days will be administered BI 201335 daily to determine if a drug interaction occurs between BI 201335 and either me...
What is the current status of trial NCT01637922?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2012-08. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01637922?
The interventions under investigation include: BI 201335 (DRUG).
Who is sponsoring clinical trial NCT01637922?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01637922's enrollment target sits among peer trials
34 1273rd of 2000 higher than 721 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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