Food Effect Study of CTP-543 in Healthy Volunteers
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/3/2019 |
| Start Date: | March 25, 2019 |
| End Date: | May 2019 |
A Phase 1 Single Center, Open-Label, Randomized Two-Period, Two-Arm Crossover Study of the Relative Bioavailability of a Single Dose of CTP-543 in Fasted and Fed Conditions in Healthy Volunteers
Two period crossover study to assess the bioavailability of CTP-543 under fed and fasted
conditions.
conditions.
This open-label, single-dose study will assess in healthy subjects a solid oral dose
formulation of CTP-543 under fasted and fed conditions.
formulation of CTP-543 under fasted and fed conditions.
Inclusion Criteria:
- Healthy adults between 18 and 55 years of age, inclusive
- Body weight not less than 100 lbs and body mass index within the range of 18 to 32
kg/m2, inclusive, at screening
Exclusion Criteria:
- History of clinically significant central nervous system (e.g., seizures), cardiac,
pulmonary, metabolic, renal, hepatic, or gastrointestinal 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
- 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
- History of drug or alcohol abuse within 6 months of screening
- History of tobacco product use within 3 months prior to the study
- Inability to comply with dietary restrictions during study participation
- Blood donation or collection within 8 week prior to dosing
- Positive pregnancy test
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