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NCT01830205 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic and Safety Study of Daclatasvir in Patients With Renal Impairment
A Phase 1 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 1
- Development phase
- 58
- Enrollment target
NCT01830205: Completed Phase 1 study, sponsored by Bristol-Myers Squibb.
NCT01830205 is a Phase 1 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 58 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01830205, a Phase 1 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 58 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the effect of renal function impairment on the single dose pharmacokinetics of Daclatasvir.
Primary Outcome
AUC(INF) was estimated by summing the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration and the extrapolated area, computed by the quotient of the last observable concentration and elimination rate constant. The pharmacokinetic (PK) analysis was based on Cockcroft-Gault (C-G) creatinine clearance (CLcr) grouping method: normal renal function, end stage renal disease (ESRD), moderate and severe renal impairment. Mild participants were
Interventions
- DRUG Daclatasvir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2012-09 |
| Est. Completion | 2013-06 |
| Phase | Phase 1 |
What the finished NCT01830205 record still lists
NCT01830205 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Daclatasvir is the first listed.
NCT01830205 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01830205 about?
NCT01830205 is a clinical study titled "Pharmacokinetic and Safety Study of Daclatasvir in Patients With Renal Impairment". The purpose of this study is to assess the effect of renal function impairment on the single dose pharmacokinetics of Daclatasvir.
What is the current status of trial NCT01830205?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 58 participants. The study started on 2012-09. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01830205?
The interventions under investigation include: Daclatasvir (DRUG).
Who is sponsoring clinical trial NCT01830205?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01830205's enrollment target sits among peer trials
58 895th of 2000 higher than 1,100 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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