Multiple Ascending Dose Study in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: CTP-730; Drug: Placebo for CTP-730

• Registration Number: NCT02404922
• Lead Sponsor: Concert Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-27
• Study First Submitted QC: 2015-03-31
• Study First Posted: 2015-04-01
• Status Verified: 2015-06
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Last Update Submitted: 2016-02-03
• Last Update Posted: 2016-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CTP-730 Mid Dose or Matching Placebo	CTP-730	Capsule, once daily
CTP-730 High Dose or Matching Placebo	Placebo for CTP-730	Capsule, once daily.
CTP-730 Low Dose or Matching Placebo	Placebo for CTP-730	Capsule, once daily.
CTP-730 Low Dose or Matching Placebo	CTP-730	Capsule, once daily.
CTP-730 Mid Dose or Matching Placebo	Placebo for CTP-730	Capsule, once daily
CTP-730 High Dose or Matching Placebo	CTP-730	Capsule, once daily.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic Profile	96 hours	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
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	24 hours	Adverse events categorized by body system and MedDRA term

Trial Locations

Locations (1)

CMAX; 🇦🇺 Adelaide, South Australia, Australia