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Trial details imported from ClinicalTrials.gov
Ethics application status
Food Effect Study of CTP-656 in Healthy Male Volunteers
A Phase 1 Single Center, Open-Label, Randomized, Three-Way Crossover Study of the Relative Bioavailability of a Single Dose of CTP-656 in a Fasted, Fed Low-Fat and Fed Moderate-Fat Condition in Healthy Male Subjects
Universal Trial Number (UTN)
Description of intervention(s) / exposure
Treatment: Drugs - CTP-656
Experimental: CTP-656 Fed, low fat - Single dose of CTP-656 150 mg administered after a low-fat breakfast
Experimental: CTP-656 Fasted - Single dose of CTP-656 150 mg administered fasted
Experimental: CTP-656 Fed, high fat - Single dose of CTP-656 150 mg administered after a moderate-fat breakfast
Treatment: Drugs: CTP-656
Intervention code 
Comparator / control treatment
Primary outcome 
Measurement of CTP-656 in plasma under fed and fasted conditions - Geometric mean ratio of moderate-fat versus low-fat or fasted
Key inclusion criteria
- Healthy adults between 18 and 50 years of age, inclusive
- Body weight = 50 kg and BMI within the range of 18 to 30 kg/m2, inclusive, at
Can healthy volunteers participate?
Key exclusion criteria
- History of clinically significant central nervous system (eg, seizures), cardiac,
pulmonary, metabolic, renal (including nephrolithiasis), hepatic, including history of
Gilbert's syndrome or gastrointestinal (GI) 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
- Liver function tests greater than the upper limit of normal.
- 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
- A positive screen for alcohol, drugs of abuse, or tobacco use.
- Inability to comply with dietary restrictions during study participation.
- Donation or blood collection or acute loss of blood prior to screening.
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?
Statistical methods / analysis
Reason for early stopping/withdrawal
Accrual to date
Recruitment hospital 
Recruitment postcode(s) 
Primary sponsor type
Ethics application status
Three way crossover study to assess the bioavailability of 656 under fed and fasted
Trial related presentations / publications
Concert Pharmaceuticals, Inc.