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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-09-30

Brief Summary

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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®.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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C-10355, 25 mg

single oral dose.

Group Type ACTIVE_COMPARATOR

C-10355

Intervention Type DRUG

C-10358, 25 mg

single oral dose.

Group Type ACTIVE_COMPARATOR

C-10358

Intervention Type DRUG

C-10355 or C-10358, 75 mg

single oral dose.

Group Type ACTIVE_COMPARATOR

C-10355

Intervention Type DRUG

C-10358

Intervention Type DRUG

C-10355 or C-10358, 150 mg

single oral dose.

Group Type ACTIVE_COMPARATOR

C-10355

Intervention Type DRUG

C-10358

Intervention Type DRUG

Kalydeco, 150 mg

single oral dose.

Group Type ACTIVE_COMPARATOR

Kalydeco

Intervention Type DRUG

C-10355 or C-10358, 300 mg

single oral dose.

Group Type ACTIVE_COMPARATOR

C-10355

Intervention Type DRUG

C-10358

Intervention Type DRUG

Interventions

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C-10355

Intervention Type DRUG

C-10358

Intervention Type DRUG

Kalydeco

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes