Safety, Tolerability, Pharmacokinetics and Early Pharmacodynamics of Single Rising Oral Doses of BI 1021958 Tablets in Healthy Male Volunteers

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses (1 mg as Drinking Solution, and 5, 20, 60, 150, 300, 500 mg as Tablets) of BI 1021958 in Healthy Male Volunteers (Placebo-controlled, Randomised and Single Blind Within Dose Groups), Including Investigation of the Effect of Food on the Bioavailability of BI 1021958 (Open-label, Randomised, Two-way Cross-over)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01541488

Enrollment

Registered

2012-03-01

Start date

2012-02-29

Completion date

Unknown

Last updated

2013-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

Safety, tolerability, pharmacokinetics and early pharmacodynamics of single rising oral doses of BI 1021958 tablets in healthy male volunteers (first-in-human trial)

Interventions

DRUGBI 1021958

tablet

DRUGPlacebo to BI 1021958

SRD part: oral administration in fasted state, FE part: oral administration in fasted state and after standard high fat breakfast

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

1\. Healthy male subjects

Exclusion criteria

1\. Any relevant deviation from healthy conditions

Design outcomes

Primary

Measure	Time frame
Number of participants with clinically relevant findings in physical examination	up to 14 days postdose
Number of participants with clinically relevant findings in vital signs	up to 14 days postdose
Number of participants with clinically significant abnormalities in electrocardiogram (ECG) results	up to 14 days postdose
Number of participants with significant changes from baseline laboratory measurements	up to 14 days postdose
Number of participants with adverse events	up to 14 days postdose
Assessment of tolerability by investigator	up to 14 days postdose

Secondary

Measure	Time frame
Cmax (maximum measured concentration of BI 1021958 in plasma)	up to 72h postdose
area under the concentration-time curve of BI 1021958 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)	up to 72h postdose
AUC0-tz (area under the concentration-time curve of BI 1021958 in plasma over the time interval from 0 up to the last quantifiable data point)	up to 72h postdose

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026