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CompletedNCT03880136Updated Jun 13, 2019

Food Effect Study of CTP-543 in Healthy Volunteers

A Phase 1 interventional study of CTP-543 in Healthy, sponsored by Concert Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-13.

Sponsored by Concert Pharmaceuticals · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Apr 2019, 7 years 6 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Healthy

Keywords

  • Safety
  • Bioavailability
  • Pharmacokinetics
03

In context

Lead sponsor

Concert Pharmaceuticals is the lead sponsor of 32 studies on the registry; none are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 7 (37%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    Sequence 1

    Period 1: CTP-543 with meal Period 2: CTP-543 without meal

    Drug: CTP-543

  • Experimental
    Sequence 2

    Period 1: CTP-543 without meal Period 2: CTP-543 with meal

    Drug: CTP-543

Interventions

  • DrugCTP-543

    Once daily dosing

06

What researchers measure

Primary outcomes

  1. Measurement of CTP-543 in plasma under fed and fasted conditions

    Time frame: 48 hours

07

Study locations

1 site
  • Celerion, Inc.
    Tempe, Arizona 85283, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03880136
Lead sponsor
Concert Pharmaceuticals
Responsible party
Sponsor
First posted
Mar 19, 2019
Start date
Mar 25, 2019
Primary completion
Apr 5, 2019
Completion
Apr 5, 2019
Last update
Jun 13, 2019

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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