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Food Effect Study of CTP-543 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03880136
Recruitment Status : Completed
First Posted : March 19, 2019
Last Update Posted : June 13, 2019
Information provided by (Responsible Party):
Concert Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Healthy Drug: CTP-543 Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : March 25, 2019
Actual Primary Completion Date : April 5, 2019
Actual Study Completion Date : April 5, 2019

Arm Intervention/treatment
Experimental: Sequence 1
Period 1: CTP-543 with meal Period 2: CTP-543 without meal
Drug: CTP-543
Once daily dosing

Experimental: Sequence 2
Period 1: CTP-543 without meal Period 2: CTP-543 with meal
Drug: CTP-543
Once daily dosing

Primary Outcome Measures :
  1. Measurement of CTP-543 in plasma under fed and fasted conditions [ Time Frame: 48 hours ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03880136

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United States, Arizona
Celerion, Inc.
Tempe, Arizona, United States, 85283
Sponsors and Collaborators
Concert Pharmaceuticals
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Responsible Party: Concert Pharmaceuticals Identifier: NCT03880136    
Other Study ID Numbers: CP543.1003
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Concert Pharmaceuticals: