Trials / Completed
CompletedNCT05046132
Study of Setmelanotide Effects on QTc (Corrected QT) Interval in Healthy Participants
A Randomized, Double-Blind, 3-arm, Parallel Group, Placebo- and Positive-controlled Study to Investigate the Effects of Setmelanotide on QTc Interval in Healthy Subjects
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 77 (actual)
- Sponsor
- Rhythm Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
This was a double-blind, randomized, placebo- and positive-controlled, parallel group, 3-arm study that assessed the potential for therapeutic and supratherapeutic concentrations of setmelanotide to affect the QTc corrected by the Fredericia method (QTcF) interval.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Setmelanotide | Administered once daily via SC injection. |
| DRUG | Moxifloxacin | Moxifloxacin capsules via oral administration. |
| DRUG | Oral Placebo | Placebo capsules via oral administration. |
| DRUG | SC Placebo | Placebo via SC injection. |
Timeline
- Start date
- 2021-08-05
- Primary completion
- 2022-04-07
- Completion
- 2022-04-07
- First posted
- 2021-09-16
- Last updated
- 2024-05-03
- Results posted
- 2024-05-03
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05046132. Inclusion in this directory is not an endorsement.