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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02599792




Registration number
NCT02599792
Ethics application status
Date submitted
5/11/2015
Date registered
9/11/2015
Date last updated
2/05/2016

Titles & IDs
Public title
Healthy Volunteer Solid Oral Dose and Multiple Ascending Dose Evaluation of CTP-656
Scientific title
A Two-Part Phase 1 Healthy Volunteer Study: A Crossover Comparison of CTP-656 Solid Dose Formulation vs. Kalydeco® and a Double-Blind, Placebo-Controlled, Ascending Multiple Dose Evaluation of CTP-656
Secondary ID [1] 0 0
CP656.1002
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
Treatment: Drugs - Placebo for CTP-656
Treatment: Drugs - Kalydeco

Experimental: CTP-656, 150 mg - Single Oral Dose

Active Comparator: Kalydeco, 150 mg - Single oral dose

Experimental: CTP-656, 75 mg or matching placebo - Subjects will be administered 75 mg CTP-656 for 7 days.

Experimental: CTP-656, 150 mg or matching placebo - Subjects will be administered 150 mg CTP-656 for 7 days.

Experimental: CTP-656, high dose or matching placebo - Subjects will be administered up to 300 mg CTP-656 for 7 days.


Treatment: Drugs: CTP-656


Treatment: Drugs: Placebo for CTP-656


Treatment: Drugs: Kalydeco
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Timepoint [1] 0 0
7 days
Primary outcome [2] 0 0
Measure exposure of test articles using area under the concentration time curve (AUC)
Timepoint [2] 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
Sex
Both males and females
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 food and beverage 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
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
1/11/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2016
Sample size
Target
Accrual to date
Final
37
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
- 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
Two-part study to assess CTP-656 dosed as a solid oral dosage form versus Kalydeco and
multiple-ascending doses of CTP-656 dosed for 7 days.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02599792
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