Trials / Completed
CompletedNCT03301298
Placebo-Controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of SXC-2023 in Healthy Volunteers
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Food Effect of SXC-2023 When Administered Orally to Healthy Adult Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Promentis Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
This is a randomized, double-blind, placebo-controlled, single ascending oral dose and food effect study conducted at one study center in the United States. Safety and tolerability will be assessed throughout the study and serial blood samples and urine samples will be collected for the safety and pharmacokinetic assessment of SXC-2023.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SXC-2023 | Oral capsule |
| DRUG | Placebo oral capsule | Placebo given as oral capsule. |
Timeline
- Start date
- 2017-09-11
- Primary completion
- 2018-02-13
- Completion
- 2018-02-13
- First posted
- 2017-10-04
- Last updated
- 2019-09-26
- Results posted
- 2019-09-26
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03301298. Inclusion in this directory is not an endorsement.