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A Phase I Study of IDP-73152 Mesylate in Health Male Volunteer

NCT01904318 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2014-02-12

No results posted yet for this study

Summary

A dose block-randomized, double-blinded, placebo-controlled, single dose, dose-escalation clinical phase I study to evaluate the safety, pharmacokinetics and food effect of IDP-73152 mesylate after oral administration in healthy male volunteer

Conditions

  • Healthy

Interventions

DRUG

IDP-73152 mesylate 40 mg

IDP-73152 mesylate 40 mg single dose administration

DRUG

IDP-73152 mesylate 80 mg

IDP-73152 mesylate 80 mg single dose administration

DRUG

IDP-73152 mesylate 160 mg

IDP-73152 mesylate 160 mg single dose administration

DRUG

IDP-73152 mesylate 320 mg

IDP-73152 mesylate 320 mg single dose administration

DRUG

IDP-73152 mesylate 640 mg

IDP-73152 mesylate 640 mg single dose administration

DRUG

IDP-73152 mesylate 1280 mg

IDP-73152 mesylate 1280 mg single dose administration

DRUG

Placebo

Placebo single dose administration

Sponsors & Collaborators

  • IlDong Pharmaceutical Co Ltd

    lead INDUSTRY

Principal Investigators

  • Kyoung Sang you, MD, PhD. · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2013-12-31
Completion
2014-01-31

Countries

  • South Korea

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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 NCT01904318 on ClinicalTrials.gov