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A Single Ascending Dose Study of PCO371 in Healthy Volunteers

NCT ID: NCT02475616

Last Updated: 2015-11-20

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

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-10-31

Brief Summary

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This is a single-center, placebo-controlled, randomized, double-blind, dose-escalation study to evaluate safety, tolerability, and PK of a single oral (PO) administration of PCO371 in healthy adult males.

Caucasian and Japanese subjects will be randomized to receive either PCO371 or placebo.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PCO371

Single oral dose of PCO371

Group Type EXPERIMENTAL

PCO371

Intervention Type DRUG

Placebo Comparator

Single oral dose of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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PCO371

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male volunteers aged 18 to 45 years.
* Caucasian(BMI 18-30 mg/kg2) or first generation japanese(BMI 18-25kg/m2)
* Able and willing to abide by the protocol

Exclusion Criteria

* Evidence of any medical condition that could affect renal, hepatic, or cardiopulmonary functions.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Chugai Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ger Rikken

Role: STUDY_DIRECTOR

Chugai Pharmaceutical

Locations

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Wcct Global

Cypress, California, United States

Site Status

Countries

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United States

Other Identifiers

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PCO001US

Identifier Type: -

Identifier Source: org_study_id