Food Effect Study of CTP-543 in Healthy Volunteers

Healthy Clinical Trial

Official title:

A Phase 1 Single Center, Open-Label, Randomized Two-Period, Two-Arm Crossover Study of the Relative Bioavailability of a Single Dose of CTP-543 in Fasted and Fed Conditions in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03880136
• Other study ID #: CP543.1003
• Status: Completed
• Phase: Phase 1
• Start date: March 25, 2019
• Est. completion date: April 5, 2019

Study information

• Verified date: June 2019
• Source: Concert Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Two period crossover study to assess the bioavailability of CTP-543 under fed and fasted conditions.

Description:

This open-label, single-dose study will assess in healthy subjects a solid oral dose formulation of CTP-543 under fasted and fed conditions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: April 5, 2019
• Est. primary completion date: April 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy adults between 18 and 55 years of age, inclusive

• Body weight not less than 100 lbs and body mass index within the range of 18 to 32 kg/m2, inclusive, at screening

Exclusion Criteria:

• History of clinically significant central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal 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

• Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody at screening

• Urinalysis positive for greater than trace blood, protein or glucose

• History of drug or alcohol abuse within 6 months of screening

• History of tobacco product use within 3 months prior to the study

• Inability to comply with dietary restrictions during study participation

• Blood donation or collection within 8 week prior to dosing

• Positive pregnancy test

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• CTP-543
Once daily dosing

Locations

Country	Name	City	State
United States	Celerion, Inc.	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Concert Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of CTP-543 in plasma under fed and fasted conditions		48 hours