A Safety and Tolerability Study of CTP-730 in Healthy Volunteers

Healthy Clinical Trial

Official title:

A Randomized, Double-blind, Single Ascending Dose, Safety, Tolerability, Pharmacokinetics Study of CTP-730 in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02239081
• Other study ID #: CP730.1001
• Status: Completed
• Phase: Phase 1
• First received: September 9, 2014
• Last updated: May 28, 2015
• Start date: September 2014
• Est. completion date: May 2015

Study information

• Verified date: May 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 is a Phase 1, single center, single-ascending dose, randomized study

Description:

Following a Screening period of up to 21 days, eight (8) subjects in each cohort, 6 subjects randomized to CTP-730 and 2 subjects randomized to placebo, will be admitted to the clinical research unit (CRU) on the evening before dosing and remain sequestered at the study site until after the last inpatient blood sample is collected at 48 hours.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: May 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy male and female volunteer subjects, 18 to 50 years of age, inclusive.

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), 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	Number and severity of adverse events		3 days	Yes
Primary	Pharmacokinetics parameters	Peak plasma concentration - Cmax by dose Area under the plasma concentration by time - AUC by dose	96 hours	No