Trials / Completed
CompletedNCT01706679
Evaluation of the Effect of ATX-101 on QT/QTc Intervals
A Four-Arm, Parallel Design, Randomized, Double-Blinded, Placebo and Active Controlled Study for the Evaluation of the Effect of Maximum Therapeutic and Supratherapeutic Single-Dose ATX-101 on the QT/QTc Intervals in Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 218 (actual)
- Sponsor
- Kythera Biopharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
To evaluate the effect of maximum therapeutic and supratherapeutic doses of ATX-101 treatment on Fridericia's corrected QT interval (QTcF).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ATX-101 (10 mg/ml) | |
| DRUG | ATX-101 (20 mg/ml) | |
| DRUG | Moxifloxacin (400 mg) | |
| DRUG | Placebo vehicle (PBS) |
Timeline
- Start date
- 2012-10-01
- Primary completion
- 2013-02-01
- Completion
- 2013-06-01
- First posted
- 2012-10-15
- Last updated
- 2013-11-14
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01706679. Inclusion in this directory is not an endorsement.