A Safety and Tolerability Study of CTP-730 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

NCT02239081

CP730.1001

Details and patient eligibility

About

This is a Phase 1, single center, single-ascending dose, randomized study

Full description

Following a Screening period of up to 21 days, eight (8) subjects in each cohort, 6 subjects randomized to CTP-730 and 2 subjects randomized to placebo, will be admitted to the clinical research unit (CRU) on the evening before dosing and remain sequestered at the study site until after the last inpatient blood sample is collected at 48 hours.

Enrollment: 55 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and female volunteer subjects, 18 to 50 years of age, inclusive.

Exclusion criteria

• Current significant medical condition, laboratory abnormality, or psychiatric illness
• 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
• Elevated liver function tests greater than twice 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.
• 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: Single Group Assignment

Masking: Quadruple Blind

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55 participants in 7 patient groups

CTP-730, 5 mg

Experimental group

Description:

oral suspension, once daily.

Treatment:

Drug: Placebo for CTP-730

Drug: CTP-730

CTP-730, 10 mg

Experimental group

Description:

Oral Suspension, once daily.

Treatment:

Drug: Placebo for CTP-730

Drug: CTP-730

CTP-730, 20 mg

Experimental group

Description:

Oral Suspension, once daily.

Treatment:

Drug: Placebo for CTP-730

Drug: CTP-730

CTP-730, 30 mg

Experimental group

Description:

Oral Suspension, once daily.

Treatment:

Drug: Placebo for CTP-730

Drug: CTP-730

CTP-730, 40 mg

Experimental group

Description:

Oral Suspension, once daily.

Treatment:

Drug: Placebo for CTP-730

Drug: CTP-730

CTP-730, 50 mg

Experimental group

Description:

Oral Suspension, once daily.

Treatment:

Drug: Placebo for CTP-730

Drug: CTP-730

CTP-730, 60 mg

Experimental group

Description:

Oral Suspension, once daily.

Treatment:

Drug: Placebo for CTP-730

Drug: CTP-730