Assessing in a sequential manner, the safety, tolerability and pharmacokinetics of multiple formulations of CTP-730 in healthy volunteers

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000511538
• Date of registration: 22/05/2015
• Prospective Registration: No
• Primary sponsor: CPR Pharma Services
• 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.
• Date of first enrolment: 08/04/2015
• Target sample size: 22
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000511538.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Crossover;Type of endpoint: Safety/efficacy;
• Phase: Phase 1

Countries of recruitment

Australia

Contacts

• Name: Dr Sepehr Shakib

• Name: Ms Ginny Braman

Key inclusion & exclusion criteria

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.
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.

Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Inflammatory and Immune System - Other inflammatory or immune system disorders

Inflammatory Diseases;
Inflammatory Diseases

Intervention(s)

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.

Primary Outcome(s)

Number of participants with Adverse Events as a Measure of Safety and Tolerability
Method of assessment: Adverse event monitoring[Safety and tolerability time frame: 24 hour]

Pharmacokinetic parameter values by cohort and treatment dose
Method of assessment: Pharmacokinetic sampling/Clinical laboratory tests
[Parameter values Time Frame: 96 hour]

Secondary Outcome(s)

Nil[Nil]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Concert Pharmaceuticals

Secondary Sponsor(s)

Concert Pharmaceuticals Inc.

Ethics review

Status: Approved
Approval date:
Contact:

Bellberry Limited