Trials / Completed
CompletedNCT02944487
A Study to Assess the Safety and Pharmacokinetics of Lucerastat (OGT 923) in Healthy Subjects
A Randomised, Double-blind, Placebo-controlled Ascending Dose Tolerance Study of OGT 923 in Healthy Male Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- Idorsia Pharmaceuticals Ltd. · Industry
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The objectives of this study were to evaluate the safety and tolerability of lucerastat, and to determine its pharmacokinetic profile as single oral doses at different strengths.
Detailed description
The subjects were enrolled sequentially to five dose groups, starting with the lowest dose level. Subjects could participate in only one Group.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lucerastat | Hard gelatin capsule for oral administration containing lucerastat |
| DRUG | Placebo | Matching placebo capsules |
Timeline
- Start date
- 2002-10-01
- Primary completion
- 2002-12-01
- Completion
- 2002-12-01
- First posted
- 2016-10-26
- Last updated
- 2025-05-01
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02944487. Inclusion in this directory is not an endorsement.