NCT03880136CompletedPhase 1
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
Concert Pharmaceuticals1 site in 1 country14 target enrollmentStarted: March 25, 2019Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Measurement of CTP-543 in plasma under fed and fasted conditions
Study Overview
Brief Summary
Two period crossover study to assess the bioavailability of CTP-543 under fed and fasted conditions.
Detailed Description
This open-label, single-dose study will assess in healthy subjects a solid oral dose formulation of CTP-543 under fasted and fed conditions.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Sequence 1
Experimental
Period 1: CTP-543 with meal Period 2: CTP-543 without meal
Intervention: CTP-543 (Drug)
Sequence 2
Experimental
Period 1: CTP-543 without meal Period 2: CTP-543 with meal
Intervention: CTP-543 (Drug)
Outcomes
Primary Outcomes
Measurement of CTP-543 in plasma under fed and fasted conditions
Time Frame: 48 hours
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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