Multiple Ascending Dose Study of CTP-692 in Healthy Volunteers

Concert Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: CTP-692

Study type: Interventional

Funder types: Industry

Identifiers

NCT03880253

CP692.1003

Details and patient eligibility

About

This study will assess in healthy male and female subjects the safety and pharmacokinetic (PK) profiles of 3 dose levels of CTP-692 following 7 days of dosing.

Enrollment: 30 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 body mass index 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: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

---

30 participants in 3 patient groups

CTP-692 Low Dose or Matching Placebo

Experimental group

Description:

Once daily dosing

Treatment:

Drug: CTP-692

CTP-692 Mid Dose or Matching Placebo

Experimental group

Description:

Once daily dosing

Treatment:

Drug: CTP-692

CTP-692 High Dose or Matching Placebo

Experimental group

Description:

Once daily dosing

Treatment:

Drug: CTP-692