Food Effect Study of CTP-543 in Healthy Volunteers

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03880136

Enrollment

Registered

2019-03-19

Start date

2019-03-25

Completion date

2019-04-05

Last updated

2019-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Safety, Bioavailability, Pharmacokinetics

Brief summary

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

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.

Interventions

DRUGCTP-543

Once daily dosing

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame
Measurement of CTP-543 in plasma under fed and fasted conditions	48 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026