Trials / Terminated
TerminatedNCT01934101
Phase 1 Dose Escalating Study to Assess Safety, Tolerability, Food Effect and PK of CHR-5154 in Healthy Male Volunteers
A Phase 1 Double-blind, Randomised, Placebo-controlled, Dose Escalating Study to Assess the Safety and Tolerability of Single and Multiple Oral Doses of CHR-5154 and the Effect of the Fasted and Fed State on Pharmacokinetics of CHR-5154 and CHR-5426 in Healthy Male Volunteers
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 64 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
Primary Objective: • To determine the safety and tolerability of single and multiple ascending oral doses of CHR-5154 in healthy volunteers. Secondary Objectives: * To determine the pharmacokinetic profile of CHR-5154 and its metabolite CHR-5426. * To compare the pharmacokinetic profile of CHR-5154 and CHR-5426 after a single dose of CHR-5154 in the fed and fasted state.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CHR-5154 | CHR-5154 |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2013-08-12
- Primary completion
- 2014-05-28
- Completion
- 2014-05-28
- First posted
- 2013-09-04
- Last updated
- 2017-05-15
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT01934101. Inclusion in this directory is not an endorsement.