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NCT01605461 · ClinicalTrials.gov registry record · Phase 1
Study Evaluating Absorption, Distribution, Metabolism and Excretion (ADME) of Single Dose [14C]-BI 207127 in Healthy Male Volunteers
A Phase 1 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT01605461: Completed Phase 1 study, sponsored by Boehringer Ingelheim.
NCT01605461 is a Phase 1 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01605461, a Phase 1 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
Phase 1 study to assess the pharmacokinetics and routes of elimination of a single oral dose of \[14C\]-BI 207127 and to characterize the metabolic profile following single dose administration.
Primary Outcome
Area under the plasma deleobuvir concentration-time curve over the time interval from 0 h extrapolated to infinity (AUC0-infinity)
Interventions
- DRUG BI 207127 NA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2012-05 |
| Est. Completion | 2012-06 |
| Phase | Phase 1 |
What the finished NCT01605461 record still lists
NCT01605461 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which BI 207127 NA is the first listed.
NCT01605461 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01605461 about?
NCT01605461 is a clinical study titled "Study Evaluating Absorption, Distribution, Metabolism and Excretion (ADME) of Single Dose [14C]-BI 207127 in Healthy Male Volunteers". Phase 1 study to assess the pharmacokinetics and routes of elimination of a single oral dose of \[14C\]-BI 207127 and to characterize the metabolic profile following single dose administration.
What is the current status of trial NCT01605461?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2012-05. Estimated completion is 2012-06.
What interventions are being tested in trial NCT01605461?
The interventions under investigation include: BI 207127 NA (DRUG).
Who is sponsoring clinical trial NCT01605461?
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 NCT01605461's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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