Trials / Completed
CompletedNCT02134964
Phase 1 Safety and PK Study of OLT1177 Capsules
A Phase 1, Randomized, Dose Escalation, Single Center, Safety and Pharmacokinetic Study of Single and Multi-Dose, Orally Administered OLT1177 Capsules in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 35 (actual)
- Sponsor
- Olatec Therapeutics LLC · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
This study is a randomized, placebo-controlled, sequential ascending-dose study of healthy volunteers after administration of single or multiple dose(s) of investigational drug (OLT1177 Caps or Placebo Caps). A total of 36 subjects will be enrolled across 6 cohorts, and subjects in each cohort will be randomized in a ratio of 5 active to 1 placebo.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OLT1177 Capsules | OLT1177 Capsules are an experimental drug. |
| DRUG | Placebo Capsules | Placebo Capsules are identical in all ways to the study drug, but contain no active pharmaceutical ingredient. |
Timeline
- Start date
- 2014-06-01
- Primary completion
- 2014-12-01
- Completion
- 2014-12-01
- First posted
- 2014-05-09
- Last updated
- 2015-03-06
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02134964. Inclusion in this directory is not an endorsement.