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NCT01135680 · ClinicalTrials.gov registry record · Phase 1
Double-Blind Randomized Crossover Trial to Access Electrocardiogram Effects of HPN-100
A Phase 1 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 98
- Enrollment target
NCT01135680: Completed Phase 1 study, sponsored by Amgen.
NCT01135680 is a Phase 1 study that has completed, run by Amgen. The registered enrollment target is 98 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01135680, a Phase 1 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 98 participants
- Enrollment target
Study Summary
Arm 1: Primary Objective: • To determine the safety and tolerability of multiple ascending, supratherapeutic doses of HPN-100. Arm 2: Primary Objective: • To assess the effects of steady-state levels of HPN-100 metabolites (4 phenylbutyric acid \[PBA\], phenylacetic acid \[PAA\], and phenylacetylglutamine \[PAGN\]) on 12-lead electrocardiogram (ECG) parameters in healthy male and female subjects with the primary endpoint being the time-matched change from baseline in the QT interval corrected for heart rate (HR) based on an individual correction method (QTcI).
Interventions
- DRUG Placebo
- DRUG Moxifloxacin
- DRUG HPN-100
- DRUG HPN-100 or Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2010-05 |
| Est. Completion | 2010-09 |
| Phase | Phase 1 |
What the finished NCT01135680 record still lists
NCT01135680 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01135680 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01135680 about?
NCT01135680 is a clinical study titled "Double-Blind Randomized Crossover Trial to Access Electrocardiogram Effects of HPN-100". Arm 1: Primary Objective: • To determine the safety and tolerability of multiple ascending, supratherapeutic doses of HPN-100. Arm 2: Primary Objective: • To assess the effects of steady-state levels of HPN-100 metabolites (4 phenylbutyric acid \[PBA\], phenylacetic acid \[PAA\], and phenylacet...
What is the current status of trial NCT01135680?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 98 participants. The study started on 2010-05. Estimated completion is 2010-09.
What interventions are being tested in trial NCT01135680?
The interventions under investigation include: Placebo (DRUG), Moxifloxacin (DRUG), HPN-100 (DRUG), HPN-100 or Placebo (DRUG).
Who is sponsoring clinical trial NCT01135680?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01135680's enrollment target sits among peer trials
98 592nd of 2000 higher than 1,404 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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