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Safety, Tolerability and Pharmacokinetics of BI 409306 Tablets in Healthy Asian Male Volunteers

NCT01841112 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2024-06-25

Study results available
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Summary

Safety, tolerability and pharmacokinetics of single and multiple oral doses of BI 409306 tablets in healthy Chinese and Japanese male volunteers of a known genotype as specified in the study protocol.

Conditions

  • Healthy

Interventions

DRUG

BI-409306 100 mg MD

Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9

DRUG

Placebo

Subjects received matching placebo to the BI-409306 (film-coated tablet/s), administered orally on day 1 for single dose (SD) segment and on day 3 to day 9 for multiple dose (MD) segment

DRUG

BI-409306 25 milligram (mg) SD

Subjects received 25 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1

DRUG

BI-409306 50 mg SD

Subjects received 50 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1

DRUG

BI-409306 100 mg SD

Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1

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
2013-04-22
Primary Completion
2013-07-18
Completion
2013-07-18

Countries

  • South Korea

Study Locations

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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 NCT01841112 on ClinicalTrials.gov