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Completed

NCT Number: NCT02777008

Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CTP-543 in Healthy Subjects

Single- and multiple-ascending dose study of CTP-543 in healthy volunteers.

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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

Adelaide, South Australia, 5000, Australia

About this study

This two-part study will assess, in healthy volunteers, under fasted conditions, and in a sequential manner, the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single- and multiple-ascending doses of CTP-543.

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, inclusive
  • Body weight ≥ 50 kg and BMI within the range of 18 to 30 kg/m2, inclusive

Exclusion criteria

  • 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 QTcF interval > 450 msec obtained at screening visit or prior to the first dose of study drug
  • History of herpes zoster
  • Hemoglobin, white blood cell, or platelet levels below the lower reference limit at screening 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
  • Urinalysis positive for protein or glucose
  • A positive screen for alcohol, drugs of abuse, or tobacco use
  • Donation of blood, plasma or other blood products prior to screening
  • A positive tuberculosis test

Treatment and study plan

CTP-543

Drug

Placebo for CTP-543

Drug

Primary outcomes

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

    Time frame: 24 hours

  2. Measurement of CTP-543 exposure in plasma under fasted conditions

    Time frame: 24 hours

Other outcomes

  1. The relationship between CTP-543 drug concentration and effect

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Concert Pharmaceuticals

Industry

Registry information

Official study title

A Two-Part Single Center, Randomized, Sequential, Single and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CTP-543 in Healthy Volunteers

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
May 19, 2016
Registry last updated
Mar 13, 2017

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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