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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Kalydeco; Drug: C-10358; Drug: C-10355

• Registration Number: NCT02392702
• Lead Sponsor: Concert Pharmaceuticals

Brief 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®.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-05
• Study First Submitted QC: 2015-03-13
• Study First Posted: 2015-03-19
• Primary Completion: 2015-06
• Status Verified: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-22
• Last Update Posted: 2015-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Healthy adults between 18 and 50 years of age, inclusive
• Body weight ≥ 50 kg and BMI within the range of 18 to 30 kg/m2, inclusive, at screening

Exclusion Criteria

• History of clinically significant central nervous system (eg, seizures), cardiac, pulmonary, metabolic, renal (including nephrolithiasis), hepatic, including history of Gilbert's syndrome or gastrointestinal (GI) conditions
• PR interval ≥ 220 msec or QRS duration ≥ 120 msec or QTcF interval > 450 msec obtained at screening visit or prior to the first dose of study drug
• Liver function tests greater than the upper limit of normal.
• Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody at screening
• Urinalysis positive for greater than trace blood, protein or glucose
• A positive screen for alcohol, drugs of abuse, or tobacco use.
• Inability to comply with food and beverage restrictions during study participation.
• Donation or blood collection or acute loss of blood prior to screening.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Kalydeco, 150 mg	Kalydeco	single oral dose.
C-10358, 25 mg	C-10358	single oral dose.
C-10355 or C-10358, 75 mg	C-10355	single oral dose.
C-10355, 25 mg	C-10355	single oral dose.
C-10355 or C-10358, 75 mg	C-10358	single oral dose.
C-10355 or C-10358, 300 mg	C-10355	single oral dose.
C-10355 or C-10358, 300 mg	C-10358	single oral dose.
C-10355 or C-10358, 150 mg	C-10355	single oral dose.
C-10355 or C-10358, 150 mg	C-10358	single oral dose.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	24 hours	adverse events categorized by body system and MedDRA term
Pharmacokinetic Profile	96 hours	Measure exposure of test articles using area under the concentration time curve (AUC), maximum concentration (Cmax), half life (T 1/2)

Trial Locations

Locations (1)

CMAX; 🇦🇺 Adelaide, South Australia, Australia