Skip to main content
OpenTrials
Completed

NCT Number: NCT02404922

Multiple Ascending Dose Study in Healthy Volunteers

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CMAX

Adelaide, South Australia, 5000, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CTP-730

Drug

Placebo for CTP-730

Drug

Primary outcomes

  1. Pharmacokinetic Profile

    Time frame: 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

  2. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Time frame: 24 hours

    Adverse events categorized by body system and MedDRA term

Sponsors and collaborators

Lead sponsor

Concert Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 1, 2015
Registry last updated
Feb 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.