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Safety, Tolerability and Pharmacokinetics of BI 113608 in Healthy Asian and Caucasian Male Volunteers

NCT01922349 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2017-01-20

Study results available
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Summary

Safety, tolerability and pharmacokinetics of single and multiple oral doses of BI 113608 in healthy Chinese, Japanese and Caucasian male volunteers.

Conditions

  • Healthy

Interventions

DRUG

BI 113608

Medium dose (Multiple dosing)

DRUG

Placebo

Placebo (Multiple dosing)

DRUG

BI 113608

Low dose (Multiple dosing)

DRUG

Placebo

Placebo (Single dosing)

DRUG

BI 113608

High dose (Single dosing)

DRUG

BI 113608

Medium dose (Single dosing)

DRUG

BI 113608

Low dose (Single dosing)

DRUG

BI 113608

High dose (Multiple dosing)

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT01922349 on ClinicalTrials.gov