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

NCT02392702 | Completed Phase 1

• 1 other identifier: CP656.1001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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®.

Conditions

Healthy

Keywords

Subjects; Safety/Efficacy Study; Randomized; Open Label

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  adverse events categorized by body system and MedDRA term

  24 hours

• Pharmacokinetic Profile

  Measure exposure of test articles using area under the concentration time curve (AUC), maximum concentration (Cmax), half life (T 1/2)

  96 hours

Study Arms (6)

C-10355, 25 mg

ACTIVE COMPARATOR

single oral dose.

Drug: C-10355

C-10358, 25 mg

ACTIVE COMPARATOR

single oral dose.

Drug: C-10358

C-10355 or C-10358, 75 mg

ACTIVE COMPARATOR

single oral dose.

Drug: C-10355; Drug: C-10358

C-10355 or C-10358, 150 mg

ACTIVE COMPARATOR

single oral dose.

Drug: C-10355; Drug: C-10358

Kalydeco, 150 mg

ACTIVE COMPARATOR

single oral dose.

Drug: Kalydeco

C-10355 or C-10358, 300 mg

ACTIVE COMPARATOR

single oral dose.

Drug: C-10355; Drug: C-10358

Interventions

C-10355 DRUG

C-10355 or C-10358, 150 mg; C-10355 or C-10358, 300 mg; C-10355 or C-10358, 75 mg; C-10355, 25 mg

C-10358 DRUG

C-10355 or C-10358, 150 mg; C-10355 or C-10358, 300 mg; C-10355 or C-10358, 75 mg; C-10358, 25 mg

Kalydeco DRUG

Kalydeco, 150 mg

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Concert Pharmaceuticals: lead

Study Sites (1)

CMAX

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Interventions

ivacaftor

Study Officials

• Lana Pilja

  Concert Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2015
• First Posted: March 19, 2015
• Study Start: March 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 23, 2015

Record last verified: 2015-09

Locations

AU (1)