Study to Evaluate Safety, Tolerability and PK of C-10355 and C-10358 in Healthy Subjects

Concert Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: C-10358; Drug: Kalydeco; Drug: C-10355

Study type: Interventional

Funder types: Industry

Identifiers

NCT02392702

CP656.1001

Details and patient eligibility

About

This two-part study will assess, in healthy volunteers, under both fasted and fed conditions, and in a sequential manner, the safety, tolerability and pharmacokinetics (PK) profile of single doses of C-10355 and C-10358 and single ascending doses of the selected compound compared to a single dose of Kalydeco®.

Enrollment: 15 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adults between 18 and 50 years of age, inclusive
• Body weight ≥ 50 kg and BMI within the range of 18 to 30 kg/m2, inclusive, at screening

Exclusion criteria

• History of clinically significant central nervous system (eg, seizures), cardiac, pulmonary, metabolic, renal (including nephrolithiasis), hepatic, including history of Gilbert's syndrome 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
• 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 greater than trace blood, 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: Crossover Assignment

Masking: None (Open label)

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15 participants in 6 patient groups

C-10355, 25 mg

Active Comparator group

Description:

single oral dose.

Treatment:

Drug: C-10355

C-10358, 25 mg

Active Comparator group

Description:

single oral dose.

Treatment:

Drug: C-10358

C-10355 or C-10358, 75 mg

Active Comparator group

Description:

single oral dose.

Treatment:

Drug: C-10355

Drug: C-10358

C-10355 or C-10358, 150 mg

Active Comparator group

Description:

single oral dose.

Treatment:

Drug: C-10355

Drug: C-10358

Kalydeco, 150 mg

Active Comparator group

Description:

single oral dose.

Treatment:

Drug: Kalydeco

C-10355 or C-10358, 300 mg

Active Comparator group

Description:

single oral dose.

Treatment:

Drug: C-10355

Drug: C-10358