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Relative Bioavailability of BI 1015550 Following Oral Administration Under Fed and Fasted Conditions in Healthy Male Subjects

NCT03302078 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-11-28

Study results available
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Summary

The primary objective of this trial is to investigate the effect of food on the pharmacokinetics of the oral tablet formulation of BI 1015550 by investigating the relative bioavailability of TF1 under fed and fasted conditions.

The assessment of safety and tolerability will be an additional objective of this part.

Conditions

  • Healthy

Interventions

DRUG

BI 1015550

Single dose of BI 1015550 4x6 mg (24 mg) tablets under fed or fasted condition

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2017-10-16
Primary Completion
2017-12-13
Completion
2017-12-13
FDA Drug
Yes

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 NCT03302078 on ClinicalTrials.gov