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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Gender
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
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
- 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/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
Other publications