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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 1021958; Drug: Placebo to BI 1021958

• Registration Number: NCT01541488
• Lead Sponsor: Boehringer Ingelheim

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-22
• Study First Submitted QC: 2012-02-29
• Study First Posted: 2012-03-01
• Primary Completion: 2012-05
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-30
• Last Update Posted: 2013-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 66

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 1021958	BI 1021958	Single rising dose (SRD) part
BI 1021958 (Food effect)	BI 1021958	Food effect part (FE)
Placebo to BI 1021958	Placebo to BI 1021958	Matching placebo as drinking solution and tablets

Primary Outcome Measures

Name	Time	Method
Number of participants with significant changes from baseline laboratory measurements	up to 14 days postdose
Assessment of tolerability by investigator	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 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 adverse events	up to 14 days postdose

Secondary Outcome Measures

Name	Time	Method
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
Cmax (maximum measured concentration of BI 1021958 in plasma)	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

Trial Locations

Locations (1)

1310.1.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany