Phase 1 Dose Escalating Study to Assess Safety, Tolerability, Food Effect and PK of CHR-5154 in Healthy Male Volunteers

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.

Timeline

Start

2013-08-12

Primary completion

2014-05-28

Completion

2014-05-28

Outcome

Outcome not reported

Stopped: “Following the emergence of an unexpected pharmacodynamic effect, the sponsor has decided to conclude the study early without fully achieving its objective”

Drugs

Indications