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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02239081




Registration number
NCT02239081
Ethics application status
Date submitted
9/09/2014
Date registered
12/09/2014
Date last updated
29/05/2015

Titles & IDs
Public title
A Safety and Tolerability Study of CTP-730 in Healthy Volunteers
Scientific title
A Randomized, Double-blind, Single Ascending Dose, Safety, Tolerability, Pharmacokinetics Study of CTP-730 in Healthy Volunteers
Secondary ID [1] 0 0
CP730.1001
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-730
Treatment: Drugs - Placebo for CTP-730

Experimental: CTP-730, 5 mg - oral suspension, once daily.

Experimental: CTP-730, 10 mg - Oral Suspension, once daily.

Experimental: CTP-730, 20 mg - Oral Suspension, once daily.

Experimental: CTP-730, 30 mg - Oral Suspension, once daily.

Experimental: CTP-730, 40 mg - Oral Suspension, once daily.

Experimental: CTP-730, 50 mg - Oral Suspension, once daily.

Experimental: CTP-730, 60 mg - Oral Suspension, 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
Number and severity of adverse events
Timepoint [1] 0 0
3 days
Primary outcome [2] 0 0
Pharmacokinetics parameters - Peak plasma concentration - Cmax by dose Area under the plasma concentration by time - AUC by dose
Timepoint [2] 0 0
96 hours

Eligibility
Key inclusion criteria
- Healthy male and female volunteer subjects, 18 to 50 years of age, inclusive.
Minimum age
18 Years
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Current significant medical condition, laboratory abnormality, or psychiatric illness

- 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

- Elevated liver function tests greater than twice 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.

- 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 assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
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 is a Phase 1, single center, single-ascending dose, randomized study
Trial website
https://clinicaltrials.gov/show/NCT02239081
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