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

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

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®.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Concert Pharmaceuticals
• Treatments: Ivacaftor

Criteria

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.