Multiple Ascending Dose Study in Healthy Volunteers

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02404922
• Other study ID #: CP730.1002
• Status: Completed
• Phase: Phase 1
• First received: March 27, 2015
• Last updated: February 3, 2016
• Start date: March 2015
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Concert Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• CTP-730

• Placebo for CTP-730

Locations

Country	Name	City	State
Australia	CMAX	Adelaide	South Australia

Sponsors (1)

Lead Sponsor	Collaborator
Concert Pharmaceuticals

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	96 hours	No
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Adverse events categorized by body system and MedDRA term	24 hours	Yes