A Safety and Tolerability Study of CTP-730 in Healthy Volunteers
- Registration Number
- NCT02239081
- Lead Sponsor
- Concert Pharmaceuticals
- Brief Summary
This is a Phase 1, single center, single-ascending dose, randomized study
- Detailed Description
Following a Screening period of up to 21 days, eight (8) subjects in each cohort, 6 subjects randomized to CTP-730 and 2 subjects randomized to placebo, will be admitted to the clinical research unit (CRU) on the evening before dosing and remain sequestered at the study site until after the last inpatient blood sample is collected at 48 hours.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
Inclusion Criteria
- Healthy male and female volunteer subjects, 18 to 50 years of age, inclusive.
Exclusion Criteria
- Current significant medical condition, laboratory abnormality, or psychiatric illness
- History of clinically significant central nervous system (eg, seizures), cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal (GI) conditions
- PR interval ≥ 220 msec or QRS duration ≥ 120 msec or QTcB / QTcF interval > 450 msec
- Elevated liver function tests greater than twice the upper limit of normal
- Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody
- Urinalysis positive for 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
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CTP-730, 60 mg Placebo for CTP-730 Oral Suspension, once daily. CTP-730, 30 mg Placebo for CTP-730 Oral Suspension, once daily. CTP-730, 40 mg CTP-730 Oral Suspension, once daily. CTP-730, 40 mg Placebo for CTP-730 Oral Suspension, once daily. CTP-730, 50 mg CTP-730 Oral Suspension, once daily. CTP-730, 50 mg Placebo for CTP-730 Oral Suspension, once daily. CTP-730, 10 mg CTP-730 Oral Suspension, once daily. CTP-730, 10 mg Placebo for CTP-730 Oral Suspension, once daily. CTP-730, 20 mg CTP-730 Oral Suspension, once daily. CTP-730, 20 mg Placebo for CTP-730 Oral Suspension, once daily. CTP-730, 30 mg CTP-730 Oral Suspension, once daily. CTP-730, 5 mg Placebo for CTP-730 oral suspension, once daily. CTP-730, 5 mg CTP-730 oral suspension, once daily. CTP-730, 60 mg CTP-730 Oral Suspension, once daily.
- Primary Outcome Measures
Name Time Method Number and severity of adverse events 3 days Pharmacokinetics parameters 96 hours Peak plasma concentration - Cmax by dose Area under the plasma concentration by time - AUC by dose
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CMAX
🇦🇺Adelaide, South Australia, Australia