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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02680249




Registration number
NCT02680249
Ethics application status
Date submitted
3/02/2016
Date registered
11/02/2016
Date last updated
2/05/2016

Titles & IDs
Public title
Food Effect Study of CTP-656 in Healthy Male Volunteers
Scientific title
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
Secondary ID [1] 0 0
CP656.1003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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 [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Measurement of CTP-656 in plasma under fed and fasted conditions - Geometric mean ratio of moderate-fat versus low-fat or fasted
Timepoint [1] 0 0
96 hours

Eligibility
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
screening
Minimum age
18 Years
Maximum age
50 Years
Gender
Males
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Basic Science
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Concert Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Three way crossover study to assess the bioavailability of 656 under fed and fasted
conditions.
Trial website
https://clinicaltrials.gov/show/NCT02680249
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lana Pilja
Address 0 0
Concert Pharmaceuticals, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications