The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02404922




Registration number
NCT02404922
Ethics application status
Date submitted
27/03/2015
Date registered
1/04/2015
Date last updated
5/02/2016

Titles & IDs
Public title
Multiple Ascending Dose Study in Healthy Volunteers
Scientific title
A Phase I Single Center, Double-Blind, Placebo-Controlled, Multiple Dose-Ascending Study to Evaluate the Pharmacokinetics and Tolerability of CTP-730 Immediate Release at Steady State in Healthy Adults
Secondary ID [1] 0 0
CP730.1002
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-730
Treatment: Drugs - Placebo for CTP-730

Experimental: CTP-730 Low Dose or Matching Placebo - Capsule, once daily.

Experimental: CTP-730 Mid Dose or Matching Placebo - Capsule, once daily

Experimental: CTP-730 High Dose or Matching Placebo - Capsule, once daily.


Treatment: Drugs: CTP-730


Treatment: Drugs: Placebo for CTP-730


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

Outcomes
Primary outcome [1] 0 0
Pharmacokinetic Profile - The primary pharmacokinetics parameters of interest will be time to attainment of steady state, and Cmax, Tmax, AUC0-24hr, AUClast and AUCinf at steady state
Timepoint [1] 0 0
96 hours
Primary outcome [2] 0 0
Number of Participants with Adverse Events as a Measure of Safety and Tolerability - Adverse events categorized by body system and MedDRA term
Timepoint [2] 0 0
24 hours

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

- Body weight = 50 kg and BMI within the range of 18 to 30 kg/m2
Minimum age
18 Years
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Medical, psychiatric illness or history of depression that could, in the
investigator's opinion, compromise the subject's safety

- Significant medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from participating in the study.

- 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 QTcB / 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 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
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
This study will assess in healthy male and female subjects the safety, tolerability and
pharmacokinetics (PK) profiles of Immediate Release CTP-730 at steady state following 7 days
of dosing. Three doses of Immediate Release (IR) CTP-730 capsules will be studied.
Trial website
https://clinicaltrials.gov/show/NCT02404922
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ginny Braman
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