Study to Assess the Safety and Pharmacokinetic (PK) of CTP-692 in Healthy Volunteers

Concert Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: CTP-692; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03830463

CP692.1002

Details and patient eligibility

About

This study will assess the safety and pharmacokinetic (PK) profile of single ascending doses of CTP-692 in healthy volunteers.

Enrollment: 42 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adult males and females between 18 and 55 years of age, inclusive
• Body weight ≥ 55 kg and BMI within the range of 18 to 32 kg/m2, inclusive

Exclusion criteria

• Screening laboratory measurements outside the normal range associated with potential risk for the treatment under investigation at screening and/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
• History of clinically significant central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal (GI) conditions
• Positive drug or alcohol test at screening or prior to the first dose of study drug

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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42 participants in 2 patient groups, including a placebo group

CTP-692

Experimental group

Treatment:

Drug: CTP-692

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo