Multiple Ascending Dose Study of CTP-692 in Healthy Volunteers

NCT ID: NCT03880253

Last Updated: 2019-06-13

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-10

Study Completion Date

2019-05-16

Brief Summary

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This study will assess in healthy male and female subjects the safety and pharmacokinetic (PK) profiles of 3 dose levels of CTP-692 following 7 days of dosing.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CTP-692 Low Dose or Matching Placebo

Once daily dosing

Group Type EXPERIMENTAL

CTP-692

Intervention Type DRUG

Placebo or CTP-692

CTP-692 Mid Dose or Matching Placebo

Once daily dosing

Group Type EXPERIMENTAL

CTP-692

Intervention Type DRUG

Placebo or CTP-692

CTP-692 High Dose or Matching Placebo

Once daily dosing

Group Type EXPERIMENTAL

CTP-692

Intervention Type DRUG

Placebo or CTP-692

Interventions

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CTP-692

Placebo or CTP-692

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy adult males and females between 18 and 55 years of age, inclusive
* Body weight ≥ 55 kg and body mass index within the range of 18 to 32 kg/m2, inclusive

Exclusion Criteria

* Screening laboratory measurements outside the normal range associated with potential risk for the treatment under investigation at screening and/or prior to the first dose of study drug
* Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen or hepatitis C virus antibody
* History of clinically significant central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal (GI) conditions
* Positive drug or alcohol test at screening or prior to the first dose of study drug
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 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

Locations

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Collaborative Neuroscience Network, LLC

Long Beach, California, United States

Site Status

Countries

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United States

Other Identifiers

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CP692.1003

Identifier Type: -

Identifier Source: org_study_id

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