Food Effect Study of CTP-543 in Healthy Volunteers
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
1 other identifier
interventional
14
1 country
1
Brief Summary
Two period crossover study to assess the bioavailability of CTP-543 under fed and fasted conditions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Mar 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2019
CompletedFirst Posted
Study publicly available on registry
March 19, 2019
CompletedStudy Start
First participant enrolled
March 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 5, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 5, 2019
CompletedJune 13, 2019
June 1, 2019
11 days
March 15, 2019
June 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measurement of CTP-543 in plasma under fed and fasted conditions
48 hours
Study Arms (2)
Sequence 1
EXPERIMENTALPeriod 1: CTP-543 with meal Period 2: CTP-543 without meal
Sequence 2
EXPERIMENTALPeriod 1: CTP-543 without meal Period 2: CTP-543 with meal
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Celerion, Inc.
Tempe, Arizona, 85283, United States
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2019
First Posted
March 19, 2019
Study Start
March 25, 2019
Primary Completion
April 5, 2019
Study Completion
April 5, 2019
Last Updated
June 13, 2019
Record last verified: 2019-06