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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/NCT02777008




Registration number
NCT02777008
Ethics application status
Date submitted
16/05/2016
Date registered
19/05/2016
Date last updated
13/03/2017

Titles & IDs
Public title
Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CTP-543 in Healthy Subjects
Scientific title
A Two-Part Single Center, Randomized, Sequential, Single and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CTP-543 in Healthy Volunteers
Secondary ID [1] 0 0
CP543.1001
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-543
Treatment: Drugs - Placebo for CTP-543

Experimental: CTP-543 Single Dose - Single oral dose

Experimental: CTP-543 Multiple Dose - Multiple oral dose for 7 consecutive days


Treatment: Drugs: CTP-543


Treatment: Drugs: Placebo for CTP-543
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
24 hours
Primary outcome [2] 0 0
Measurement of CTP-543 exposure in plasma under fasted conditions
Timepoint [2] 0 0
24 hours

Eligibility
Key inclusion criteria
- Healthy adult males and females between 18 and 50 years of age, inclusive

- Body weight = 50 kg and BMI within the range of 18 to 30 kg/m2, inclusive
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, hepatic, 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

- History of herpes zoster

- Hemoglobin, white blood cell, or platelet levels below the lower reference limit at
screening 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

- Urinalysis positive for protein or glucose

- A positive screen for alcohol, drugs of abuse, or tobacco use

- Donation of blood, plasma or other blood products prior to screening

- A positive tuberculosis test

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
1/05/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2017
Sample size
Target
Accrual to date
Final
77
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
Single- and multiple-ascending dose study of CTP-543 in healthy volunteers.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02777008
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Colleen Hamilton
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02777008