Healthy
Conditions
Brief summary
This study will assess in healthy male and female subjects the safety and pharmacokinetic (PK) profiles of 3 dose levels of CTP-692 following 7 days of dosing.
Interventions
DRUGCTP-692
Placebo or CTP-692
Sponsors
Concert Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adult males and females between 18 and 55 years of age, inclusive * Body weight ≥ 55 kg and body mass index within the range of 18 to 32 kg/m2, inclusive
Exclusion criteria
* Screening laboratory measurements outside the normal range associated with potential risk for the treatment under investigation at screening and/or prior to the first dose of study drug * Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen or hepatitis C virus antibody * History of clinically significant central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal (GI) conditions * Positive drug or alcohol test at screening or prior to the first dose of study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events as a measure of safety | Assessments done Day 1 - 9 |
| Measurement of CTP-692 exposure in plasma | Assessments done Day 1 - 9 |
Countries
United States
Outcome results
None listed