NCT02392702

Study to Evaluate Safety, Tolerability and PK of C-10355 and C-10358 in Healthy Subjects

A Two-Part Open-Label, Randomized, Sequential, Crossover, Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of C-10355 and C-10358 in Healthy Volunteers, With a PK Comparison to Kalydeco®

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Concert Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This two-part study will assess, in healthy volunteers, under both fasted and fed conditions, and in a sequential manner, the safety, tolerability and pharmacokinetics (PK) profile of single doses of C-10355 and C-10358 and single ascending doses of the selected compound compared to a single dose of Kalydeco®.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	C-10355
DRUG	C-10358
DRUG	Kalydeco

Timeline

• Start date: 2015-03-01
• Primary completion: 2015-06-01
• Completion: 2015-09-01
• First posted: 2015-03-19
• Last updated: 2015-09-23

Locations

1 site across 1 country: Australia