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

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

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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CTP-656, 150 mg

Single Oral Dose

Group Type EXPERIMENTAL

CTP-656

Intervention Type DRUG

Kalydeco, 150 mg

Single oral dose

Group Type ACTIVE_COMPARATOR

Kalydeco

Intervention Type DRUG

CTP-656, 75 mg or matching placebo

Subjects will be administered 75 mg CTP-656 for 7 days.

Group Type EXPERIMENTAL

CTP-656

Intervention Type DRUG

Placebo for CTP-656

Intervention Type DRUG

CTP-656, 150 mg or matching placebo

Subjects will be administered 150 mg CTP-656 for 7 days.

Group Type EXPERIMENTAL

CTP-656

Intervention Type DRUG

Placebo for CTP-656

Intervention Type DRUG

CTP-656, high dose or matching placebo

Subjects will be administered up to 300 mg CTP-656 for 7 days.

Group Type EXPERIMENTAL

CTP-656

Intervention Type DRUG

Placebo for CTP-656

Intervention Type DRUG

Interventions

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CTP-656

Intervention Type DRUG

Placebo for CTP-656

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