Healthy Volunteer Solid Oral Dose and Multiple Ascending Dose Evaluation of CTP-656
- Registration Number
- NCT02599792
- Lead Sponsor
- Concert Pharmaceuticals
- Brief Summary
Two-part study to assess CTP-656 dosed as a solid oral dosage form versus Kalydeco and multiple-ascending doses of CTP-656 dosed for 7 days.
- Detailed Description
This two-part study will assess in healthy male and female subjects a solid oral dose formulation of CTP-656 vs. Kalydeco® and the safety, tolerability and pharmacokinetic profiles of escalating CTP-656 solid oral doses following 7 days of dosing. In Part B, three doses of CTP-656 ranging from 75 mg up to 300 mg per day will be studied.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
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
- PARALLEL
- Arm && Interventions
Group Intervention Description CTP-656, 150 mg or matching placebo Placebo for CTP-656 Subjects will be administered 150 mg CTP-656 for 7 days. CTP-656, high dose or matching placebo CTP-656 Subjects will be administered up to 300 mg CTP-656 for 7 days. CTP-656, high dose or matching placebo Placebo for CTP-656 Subjects will be administered up to 300 mg CTP-656 for 7 days. CTP-656, 150 mg CTP-656 Single Oral Dose Kalydeco, 150 mg Kalydeco Single oral dose CTP-656, 75 mg or matching placebo CTP-656 Subjects will be administered 75 mg CTP-656 for 7 days. CTP-656, 75 mg or matching placebo Placebo for CTP-656 Subjects will be administered 75 mg CTP-656 for 7 days. CTP-656, 150 mg or matching placebo CTP-656 Subjects will be administered 150 mg CTP-656 for 7 days.
- Primary Outcome Measures
Name Time Method Number of Participants with Adverse Events as a Measure of Safety and Tolerability 7 days adverse events categorized by body system and MedDRA term
Measure exposure of test articles using area under the concentration time curve (AUC) 96 hours
- Secondary Outcome Measures
Name Time Method