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NCT01737866 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics Study of AMG 423 in Healthy Subjects and Subjects With Various Degrees of Renal Insufficiency
A Phase 1 study, sponsored by Cytokinetics.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT01737866: Completed Phase 1 study, sponsored by Cytokinetics.
NCT01737866 is a Phase 1 study that has completed, run by Cytokinetics. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01737866, a Phase 1 study, has completed, sponsored by Cytokinetics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
A phase 1, open-label study in subjects with normal renal function and subjects with various degrees of renal insufficiency, including patients with end-stage renal disease (ESRD) requiring hemodialysis. The primary objective is to evaluate the single-dose PK of AMG 423 in subjects with various degrees of renal insufficiency, including patients with end-stage renal disease requiring hemodialysis.
Primary Outcome
Part A and Part B: Total AMG 423 pharmacokinetic parameters including area under the plasma concentration time curve (AUC) from time 0 to the time of the last quantifiable sample (AUC0-t) and maximum observed plasma concentration after dosing (Cmax).
Interventions
- DRUG AMG 423
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2012-11 |
| Est. Completion | 2013-05 |
| Phase | Phase 1 |
What the finished NCT01737866 record still lists
NCT01737866 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 1 intervention - of which AMG 423 is the first listed.
NCT01737866 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01737866 about?
NCT01737866 is a clinical study titled "Pharmacokinetics Study of AMG 423 in Healthy Subjects and Subjects With Various Degrees of Renal Insufficiency". A phase 1, open-label study in subjects with normal renal function and subjects with various degrees of renal insufficiency, including patients with end-stage renal disease (ESRD) requiring hemodialysis. The primary objective is to evaluate the single-dose PK of AMG 423 in subjects with various degr...
What is the current status of trial NCT01737866?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2012-11. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01737866?
The interventions under investigation include: AMG 423 (DRUG).
Who is sponsoring clinical trial NCT01737866?
This trial is sponsored by Cytokinetics, which has 31 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01737866's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 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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