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This Study Tests How Different Doses of BI 1291583 Are Taken up in the Body and How Well They Are Tolerated

NCT03414008 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-08-13

No results posted yet for this study

Summary

The primary objective of this trial is to investigate the safety and tolerability of BI 1291583 in healthy male subjects following oral administration of single rising doses.

Secondary objectives are the exploration of the pharmacokinetics (PK) including dose proportionality and pharmacodynamics (PD) of BI 1291583 after single dosing.

Conditions

  • Healthy

Interventions

DRUG

BI 1291583

Single dose

DRUG

Matching placebo: Tartaric acid

Single dose

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
2018-02-05
Primary Completion
2019-11-18
Completion
2019-11-18

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 NCT03414008 on ClinicalTrials.gov