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

April 29, 2016 updated by: Concert Pharmaceuticals

A Two-Part Phase 1 Healthy Volunteer Study: A Crossover Comparison of CTP-656 Solid Dose Formulation vs. Kalydeco® and a Double-Blind, Placebo-Controlled, Ascending Multiple Dose Evaluation of CTP-656

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

37

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CTP-656, 150 mg
Single Oral Dose
Drug: CTP-656
Active Comparator: Kalydeco, 150 mg
Single oral dose
Drug: Kalydeco
Experimental: CTP-656, 75 mg or matching placebo
Subjects will be administered 75 mg CTP-656 for 7 days.
Drug: CTP-656
Drug: Placebo for CTP-656
Experimental: CTP-656, 150 mg or matching placebo
Subjects will be administered 150 mg CTP-656 for 7 days.
Drug: CTP-656
Drug: Placebo for CTP-656
Experimental: CTP-656, high dose or matching placebo
Subjects will be administered up to 300 mg CTP-656 for 7 days.
Drug: CTP-656
Drug: Placebo for CTP-656

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 7 days
adverse events categorized by body system and MedDRA term
7 days
Measure exposure of test articles using area under the concentration time curve (AUC)
Time Frame: 96 hours
96 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Concert Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

November 5, 2015

First Submitted That Met QC Criteria

November 6, 2015

First Posted (Estimate)

November 9, 2015

Study Record Updates

Last Update Posted (Estimate)

May 2, 2016

Last Update Submitted That Met QC Criteria

April 29, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP656.1002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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