Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 655130 in Healthy Male Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 655130 (spesolimab); Drug: Placebo

• Registration Number: NCT02525679
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The aim of this study is to investigate the safety and tolerability of BI 655130 in healthy male subjects following single rising low, medium and high doses.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-14
• Study First Submitted QC: 2015-08-14
• Study First Posted: 2015-08-17
• Study Start: 2015-09-14
• Primary Completion: 2016-05-27
• Study Completion: 2016-05-27
• Results First Submitted: 2022-09-26
• Status Verified: 2023-09
• Results First Submitted QC: 2023-09-05
• Last Update Submitted: 2023-09-05
• Results First Posted: 2024-03-15
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 78

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 655130 (spesolimab)	BI 655130 (spesolimab)	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Drug Related Adverse Events	Adverse events reported until the end-of-trial examination; up to day 74	Percentage of subjects with drug related adverse events are presented.

Secondary Outcome Measures

Name	Time	Method
Maximum Measured Concentration of BI 655130 in Plasma (Cmax)	-2 hours (h) before and 0.5h, 1h, 2h, 3h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h, 1008h, 1344h, 1680h after drug administration	Maximum measured concentration of BI 655130 in plasma (Cmax) is presented.
Area Under the Concentration-time Curve of the BI 655130 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)	-2 hours (h) before and 0.5h, 1h, 2h, 3h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h, 1008h, 1344h, 1680h after drug administration	Area under the concentration-time curve of the BI 655130 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is presented.; Reliable values of AUC0-∞ could not be calculated because concentrations were too high at the last PK sample collected "1680h" after drug administration. AUC0-tz was utilized for the dose proportionality analyses instead of AUC0-∞.
Area Under the Concentration-time Curve of the BI 655130 in Plasma Over the Time Interval From 0 to the Last Measurable Plasma Concentration (AUC0-tz)	-2 hours (h) before and 0.5h, 1h, 2h, 3h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h, 1008h, 1344h, 1680h after drug administration	Area under the concentration-time curve of the BI 655130 in plasma over the time interval from 0 to the last measurable plasma concentration (AUC0-tz) is presented.

Trial Locations

Locations (1)

SGS Life Science Services - Clinical Research; 🇧🇪 Antwerpen, Belgium