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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 is a Phase 1 study that has completed, run by Amgen. The registered enrollment target is 98 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01135680
The ClinicalTrials.gov registry entry for NCT01135680 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01135680 reports 0 study locations.
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.
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