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Completed

NCT Number: NCT02239081

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

This is a Phase 1, single center, single-ascending dose, randomized study

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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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

CTP-730

Drug

Placebo for CTP-730

Drug

Primary outcomes

  1. Number and severity of adverse events

    Time frame: 3 days

  2. Pharmacokinetics parameters

    Time frame: 96 hours

    Peak plasma concentration - Cmax by dose Area under the plasma concentration by time - AUC by dose

Sponsors and collaborators

Lead sponsor

Concert Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 12, 2014
Registry last updated
May 29, 2015

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.

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