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A Single Ascending Dose Study of PCO371 in Healthy Volunteers

NCT02475616 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2015-11-20

No results posted yet for this study

Summary

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.

Conditions

  • Healthy

Interventions

DRUG

PCO371

DRUG

Placebo

Sponsors & Collaborators

  • Chugai Pharmaceutical

    lead INDUSTRY

Principal Investigators

  • Ger Rikken · Chugai Pharmaceutical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02475616 on ClinicalTrials.gov