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

NCT02392702 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2015-09-23

No results posted yet for this study

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

DRUG

C-10355

DRUG

C-10358

DRUG

Kalydeco

Sponsors & Collaborators

  • Concert Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Lana Pilja · Concert Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-06-30
Completion
2015-09-30

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02392702 on ClinicalTrials.gov