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This Study Tests How Healthy Men Tolerate Different Doses of BI1015550. The Study Also Tests How BI 1015550 is Taken up by the Body

NCT03230487 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-11-28

Study results available
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Summary

Part 1 (SRD (Single-rising dose)):

The primary objective of this trial part is to investigate the safety and tolerability of BI 1015550 in healthy male subjects following oral administration of single rising doses.

Secondary objectives are the exploration of the pharmacokinetics of BI 1015550 after single dosing.

Part 2 (MRD (Multiple-rising dose)):

In Part 2, the primary objective is to investigate the safety and tolerability of BI 1015550 in healthy male subjects following oral administration of multiple rising doses.

Secondary objectives are the exploration of the pharmacokinetics of BI 1015550 after multiple dosing.

Conditions

  • Healthy

Interventions

DRUG

Placebo Single Dose (SD)

Subjects received single dose of placebo tablet matching to BI 1015550 orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours

DRUG

BI 1015550 Single Dose (SD)

Subjects received single dose of BI 1015550 orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours

DRUG

Placebo Multiple Dose (MD)

Subjects received placebo tablet matching to BI 1015550 twice daily (bid) orally with 240 milligram (mL) of water after a moderate fat meal.

DRUG

BI 1015550 Multiple Dose (MD)

Subjects received BI 1015550 twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-08-10
Primary Completion
2018-01-16
Completion
2018-01-16

Countries

  • Germany

Study Locations

More Related Trials

Entities

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 NCT03230487 on ClinicalTrials.gov