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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02777008
• Other study ID #: CP543.1001
• Status: Completed
• Phase: Phase 1
• First received: May 16, 2016
• Last updated: March 10, 2017
• Start date: May 2016
• Est. completion date: March 2017

Study information

• Verified date: March 2017
• Source: Concert Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• CTP-543

• Placebo for CTP-543

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Concert Pharmaceuticals

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The relationship between CTP-543 drug concentration and effect		7 days
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		24 hours
Primary	Measurement of CTP-543 exposure in plasma under fasted conditions		24 hours