Trials / Completed
CompletedNCT03395470
Safety, Tolerability and PK of PXL770 in Healthy Male Subjects
A Double-blind, Randomised, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of PXL770, Including an Open-label, One-sequence Part to Assess the Drug-drug Interaction With Rosuvastatin in Healthy Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Poxel SA · Industry
- Sex
- Male
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
PXL770 is a direct activator of 5' adenosine monophosphate-activated protein kinase (AMPK) being developed by Poxel S.A. for the treatment of type 2 diabetes mellitus (T2DM). In Part A of this study, we'll test the safety, tolerability and pharmacokinetics (PK) of repeated doses. In Part B, we'll co-administer PXL770 and rosuvastatin (a HMG-CoA reductase inhibitor) to assess any drug-drug interaction.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PXL770 | MAD |
| DRUG | Placebo | MAD |
| DRUG | Rosuvastatin | DDI |
Timeline
- Start date
- 2017-08-21
- Primary completion
- 2018-03-16
- Completion
- 2018-03-16
- First posted
- 2018-01-10
- Last updated
- 2018-08-24
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT03395470. Inclusion in this directory is not an endorsement.