Food Effect Study of CTP-543 in Healthy Volunteers

Completed · Phase 1

Conditions studied: Healthy

In brief

Two period crossover study to assess the bioavailability of CTP-543 under fed and fasted conditions.

Key facts

Study ID

NCT03880136

Run by

Concert Pharmaceuticals

People needed

14

Starts

2019-03-25

Expected to finish

2019-04-05

Last updated by the study team

2019-06-13

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Celerion, Inc. — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

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