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

Concert Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: CTP-543; Drug: Placebo for CTP-543

Study type: Interventional

Funder types: Industry

Identifiers

NCT02777008

CP543.1001

Details and patient eligibility

About

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

Full 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.

Enrollment: 77 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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77 participants in 2 patient groups

CTP-543 Single Dose

Experimental group

Description:

Single oral dose

Treatment:

Drug: Placebo for CTP-543

Drug: CTP-543

CTP-543 Multiple Dose

Experimental group

Description:

Multiple oral dose for 7 consecutive days

Treatment:

Drug: Placebo for CTP-543

Drug: CTP-543