Study to Assess the Safety and Pharmacokinetic (PK) of CTP-692 in Healthy Volunteers
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/6/2019 |
| Start Date: | January 24, 2019 |
| End Date: | May 2019 |
A Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety and Pharmacokinetic Profile of CTP-692 in Fed and Fasted Conditions in Healthy Volunteers
This study will assess the safety and pharmacokinetic (PK) profile of single ascending doses
of CTP-692 in healthy volunteers.
of CTP-692 in healthy volunteers.
Inclusion Criteria:
- Healthy adult males and females between 18 and 55 years of age, inclusive
- Body weight ≥ 55 kg and BMI 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
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