A Safety and Tolerability Study of CTP-730 in Healthy Volunteers

May 28, 2015 updated by: Concert Pharmaceuticals

A Randomized, Double-blind, Single Ascending Dose, Safety, Tolerability, Pharmacokinetics Study of CTP-730 in Healthy Volunteers

This is a Phase 1, single center, single-ascending dose, randomized study

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Following a Screening period of up to 21 days, eight (8) subjects in each cohort, 6 subjects randomized to CTP-730 and 2 subjects randomized to placebo, will be admitted to the clinical research unit (CRU) on the evening before dosing and remain sequestered at the study site until after the last inpatient blood sample is collected at 48 hours.

Study Type

Interventional

Enrollment (Actual)

55

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
        • CMAX

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

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy male and female volunteer subjects, 18 to 50 years of age, inclusive.

Exclusion Criteria:

  • Current significant medical condition, laboratory abnormality, or psychiatric illness
  • History of clinically significant central nervous system (eg, seizures), cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal (GI) conditions
  • PR interval ≥ 220 msec or QRS duration ≥ 120 msec or QTcB / QTcF interval > 450 msec
  • Elevated liver function tests greater than twice the upper limit of normal
  • Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody
  • Urinalysis positive for 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: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CTP-730, 5 mg
oral suspension, once daily.
Drug: CTP-730
Drug: Placebo for CTP-730
Experimental: CTP-730, 10 mg
Oral Suspension, once daily.
Drug: CTP-730
Drug: Placebo for CTP-730
Experimental: CTP-730, 20 mg
Oral Suspension, once daily.
Drug: CTP-730
Drug: Placebo for CTP-730
Experimental: CTP-730, 30 mg
Oral Suspension, once daily.
Drug: CTP-730
Drug: Placebo for CTP-730
Experimental: CTP-730, 40 mg
Oral Suspension, once daily.
Drug: CTP-730
Drug: Placebo for CTP-730
Experimental: CTP-730, 50 mg
Oral Suspension, once daily.
Drug: CTP-730
Drug: Placebo for CTP-730
Experimental: CTP-730, 60 mg
Oral Suspension, once daily.
Drug: CTP-730
Drug: Placebo for CTP-730

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and severity of adverse events
Time Frame: 3 days
3 days
Pharmacokinetics parameters
Time Frame: 96 hours
Peak plasma concentration - Cmax by dose Area under the plasma concentration by time - AUC by dose
96 hours

Collaborators and Investigators

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

Sponsor

Concert Pharmaceuticals

Investigators

  • Study Director: Ginny Braman, Concert Pharmaceuticals, Inc.

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

September 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

September 9, 2014

First Submitted That Met QC Criteria

September 10, 2014

First Posted (Estimate)

September 12, 2014

Study Record Updates

Last Update Posted (Estimate)

May 29, 2015

Last Update Submitted That Met QC Criteria

May 28, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CP730.1001

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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