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

NCT ID: NCT02239081

Last Updated: 2015-05-29

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

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Healthy

Keywords

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Pharmacokinetics Safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CTP-730, 5 mg

oral suspension, once daily.

Group Type EXPERIMENTAL

CTP-730

Intervention Type DRUG

Placebo for CTP-730

Intervention Type DRUG

CTP-730, 10 mg

Oral Suspension, once daily.

Group Type EXPERIMENTAL

CTP-730

Intervention Type DRUG

Placebo for CTP-730

Intervention Type DRUG

CTP-730, 20 mg

Oral Suspension, once daily.

Group Type EXPERIMENTAL

CTP-730

Intervention Type DRUG

Placebo for CTP-730

Intervention Type DRUG

CTP-730, 30 mg

Oral Suspension, once daily.

Group Type EXPERIMENTAL

CTP-730

Intervention Type DRUG

Placebo for CTP-730

Intervention Type DRUG

CTP-730, 40 mg

Oral Suspension, once daily.

Group Type EXPERIMENTAL

CTP-730

Intervention Type DRUG

Placebo for CTP-730

Intervention Type DRUG

CTP-730, 50 mg

Oral Suspension, once daily.

Group Type EXPERIMENTAL

CTP-730

Intervention Type DRUG

Placebo for CTP-730

Intervention Type DRUG

CTP-730, 60 mg

Oral Suspension, once daily.

Group Type EXPERIMENTAL

CTP-730

Intervention Type DRUG

Placebo for CTP-730

Intervention Type DRUG

Interventions

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CTP-730

Intervention Type DRUG

Placebo for CTP-730

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Concert Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ginny Braman

Role: STUDY_DIRECTOR

Concert Pharmaceuticals, Inc.

Locations

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CMAX

Adelaide, South Australia, Australia

Site Status

Countries

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Australia

Other Identifiers

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CP730.1001

Identifier Type: -

Identifier Source: org_study_id