Multiple Ascending Dose Study in Healthy Volunteers

Concert Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo for CTP-730; Drug: CTP-730

Study type: Interventional

Funder types: Industry

Identifiers

NCT02404922

CP730.1002

Details and patient eligibility

About

This study will assess in healthy male and female subjects the safety, tolerability and pharmacokinetics (PK) profiles of Immediate Release CTP-730 at steady state following 7 days of dosing. Three doses of Immediate Release (IR) CTP-730 capsules will be studied.

Enrollment: 30 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.
• Body weight ≥ 50 kg and BMI within the range of 18 to 30 kg/m2

Exclusion criteria

• Medical, psychiatric illness or history of depression that could, in the investigator's opinion, compromise the subject's safety
• Significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
• 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 QTcB / QTcF interval > 450 msec obtained at screening visit 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 at screening.
• Urinalysis positive for protein or glucose.
• A positive screen for alcohol, drugs of abuse, or tobacco use.
• Inability to comply with food and beverage restrictions during study participation.
• Donation or blood collection or acute loss of blood prior to screening.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 3 patient groups

CTP-730 Low Dose or Matching Placebo

Experimental group

Description:

Capsule, once daily.

Treatment:

Drug: CTP-730

Drug: Placebo for CTP-730

CTP-730 Mid Dose or Matching Placebo

Experimental group

Description:

Capsule, once daily

Treatment:

Drug: CTP-730

Drug: Placebo for CTP-730

CTP-730 High Dose or Matching Placebo

Experimental group

Description:

Capsule, once daily.

Treatment:

Drug: CTP-730

Drug: Placebo for CTP-730