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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02777008

Enrollment

Registered

2016-05-19

Start date

2016-05-31

Completion date

2017-03-31

Last updated

2017-03-13

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

Conditions

Healthy

Brief summary

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

Detailed 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.

Interventions

DRUGCTP-543

DRUGPlacebo for CTP-543

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	24 hours
Measurement of CTP-543 exposure in plasma under fasted conditions	24 hours

Other

Measure	Time frame
The relationship between CTP-543 drug concentration and effect	7 days

Countries

Australia

Outcome results

None listed

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