Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000511538
Ethics application status
Approved
Date submitted
9/04/2015
Date registered
22/05/2015
Date last updated
27/04/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessing in a sequential manner, the safety, tolerability and pharmacokinetics of multiple formulations of CTP-730 in healthy volunteers
Scientific title
A Two-Part Study of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Immediate and Delayed Release Formulations of CTP-730 in Healthy Volunteers.
Secondary ID [1] 286498 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory Diseases 294679 0
Condition category
Condition code
Inflammatory and Immune System 294982 294982 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Drug: CTP-730
Drug: Placebo for CTP-730

Part 1: Four (4) dose/formulation combinations in total will be studied, with the first 3 formulations studied in a 3-period randomized, double-blind crossover fashion and the 4th formulation (a composite formulation, determined based on outcomes from the crossover) will not be randomized. 40mg will be administered once a day for Part 1.

Part 1 subjects will receive a single dose of CTP-730 in the morning following an overnight fast. Subjects will remain sequestered at the site until the last PK blood sample is collected at 48 hours post dose.

Part 2: A multi-dose exploration of the composite formulation of CTP-730 selected from Part 1, for 7-days. Up to 80mg will be administered once a day for 7 days.

The dose to be administered in Part 2 will be determined based on information obtained from Part 1 of the study. A single dose of the composite formulation will be administered daily for a total of 7 days.

Drug will be in the form of oral capsules.

Pharmacokinetic blood samples will be taken to monitor adherence to the intervention.

There is a 7 day washout period between each period in Part 1.
Intervention code [1] 291576 0
Treatment: Drugs
Comparator / control treatment
Placebo - Lactose Monohydrate

Placebo capsules will be administered in Part 2 of the study only. Part 2 will be conducted under a placebo controlled, randomized, double-blind design. A total of 10 subjects will be selected for Part 2 of the study where 8 subjects will be randomized to receive active treatment and 2 to placebo.
Control group
Placebo

Outcomes
Primary outcome [1] 294733 0
Pharmacokinetic parameter values by cohort and treatment dose
Method of assessment: Pharmacokinetic sampling/Clinical laboratory tests
Timepoint [1] 294733 0
Parameter values Time Frame: 96 hour
Primary outcome [2] 294840 0
Number of participants with Adverse Events as a Measure of Safety and Tolerability
Method of assessment: Adverse event monitoring
Timepoint [2] 294840 0
Safety and tolerability time frame: 24 hour
Secondary outcome [1] 313959 0
Nil
Timepoint [1] 313959 0
Nil

Eligibility
Key inclusion criteria
1. Healthy adult males and females between 18 and 50 years of age.
2. Body weight >/= 50 kg and BMI within the range of 18 to 30 kg/m2.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Medical, psychiatric illness or history of depression that could, in the investigator’s opinion, compromise the
subject’s safety.
2. Significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject
from participating in the study.
3. History of clinically significant central nervous system (eg, seizures), cardiac, pulmonary, metabolic, renal,
hepatic, or gastrointestinal (GI) conditions.
4. 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.
5. Liver function tests greater than the upper limit of normal.
6. Positive screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or
hepatitis C virus antibody at screening.
7. Urinalysis positive for protein or glucose.
8. A positive screen for alcohol, drugs of abuse, or tobacco use.
9. Inability to comply with food and beverage restrictions during study participation.
10. Donation or blood collection or acute loss of blood prior to screening.

Study design
Purpose of the study
Treatment
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
Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/03/2015
Actual
8/04/2015
Date of last participant enrolment
Anticipated
1/07/2015
Actual
24/06/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
22
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 3673 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 9502 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 291052 0
Commercial sector/Industry
Name [1] 291052 0
Concert Pharmaceuticals
Country [1] 291052 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
CPR Pharma Services
Address
28 Dalgleish Street
Thebarton SA 5031
Country
Australia
Secondary sponsor category [1] 289734 0
Commercial sector/Industry
Name [1] 289734 0
Concert Pharmaceuticals Inc.
Address [1] 289734 0
199 Hayden Avenue, Suite 500
Lexington, MA 02421
Country [1] 289734 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292634 0
Bellberry Limited
Ethics committee address [1] 292634 0
129 Glen Osmond Road
Eastwood, South Australia 5063
Ethics committee country [1] 292634 0
Australia
Date submitted for ethics approval [1] 292634 0
23/12/2014
Approval date [1] 292634 0
30/01/2015
Ethics approval number [1] 292634 0
2014-12-717-A-2

Summary
Brief summary
This study will assess consecutively the safety, tolerability, and pharmacokinetics of single and multiple doses of CTP-730 in healthy volunteers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56334 0
Dr Sepehr Shakib
Address 56334 0
CMAX
Level 5, East Wing
Royal Adelaide Hospital
North Terrace
Adelaide, South Australia 5000
Country 56334 0
Australia
Phone 56334 0
+61 8 8222 3923
Fax 56334 0
Email 56334 0
[email protected]
Contact person for public queries
Name 56335 0
Dr Sepehr Shakib
Address 56335 0
CMAX
Level 5 East Wing
Royal Adelaide Hospital
North Terrace, Adelaide,
South Australia 5000
Australia
Country 56335 0
Australia
Phone 56335 0
+61 8 8222 3923
Fax 56335 0
Email 56335 0
[email protected]
Contact person for scientific queries
Name 56336 0
Ms Ginny Braman
Address 56336 0
Concert Pharmaceuticals Inc.
99 Hayden Avenue, Suite 500
Lexington, MA 02421
Country 56336 0
United States of America
Phone 56336 0
781.860.0045
Fax 56336 0
Email 56336 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.