Healthy Volunteer Solid Oral Dose and Multiple Ascending Dose Evaluation of CTP-656

Concert Pharmaceuticals37 enrolled

Overview

Two-part study to assess CTP-656 dosed as a solid oral dosage form versus Kalydeco and multiple-ascending doses of CTP-656 dosed for 7 days.

This two-part study will assess in healthy male and female subjects a solid oral dose formulation of CTP-656 vs. Kalydeco® and the safety, tolerability and pharmacokinetic profiles of escalating CTP-656 solid oral doses following 7 days of dosing. In Part B, three doses of CTP-656 ranging from 75 mg up to 300 mg per day will be studied.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Healthy

Interventions

CTP-656DRUG

Placebo for CTP-656DRUG

KalydecoDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Adelaide, South Australia, Australia

Outcomes

Primary Outcomes

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

adverse events categorized by body system and MedDRA term

Time frame: 7 days

Measure exposure of test articles using area under the concentration time curve (AUC)

Time frame: 96 hours

Data from ClinicalTrials.gov

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