To Assess Safety, Tolerability and Pharmacokinetics of BI 443651 in Healthy Male Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 443651; Drug: Placebo

• Registration Number: NCT02706925
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To investigate safety, tolerability and pharmacokinetics, following single doses of BI 443651

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-03
• Study First Submitted QC: 2016-03-08
• Study First Posted: 2016-03-11
• Study Start: 2016-03-22
• Primary Completion: 2016-06-12
• Study Completion: 2016-06-13
• Results First Submitted: 2019-11-07
• Status Verified: 2019-12
• Results First Submitted QC: 2019-12-11
• Last Update Submitted: 2019-12-11
• Results First Posted: 2020-01-02
• Last Update Posted: 2020-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 63

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 443651	BI 443651	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Drug-related Adverse Events (AEs)	Up to 216 hours.	This outcome measure presents percentage of the subjects with drug-related AEs. The doses ranged from 10 μg to 3600 μg for the outcome measure \[Percentage of subjects with drug-related Adverse Events (AEs)\].

Secondary Outcome Measures

Name	Time	Method
AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point)	1.30 (hours: minutes) hours (h) before drug administration and 0:05h, 0:10h, 0:15h, 0:20h, 0:30h, 0:40h, 0:50h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h, 96:00h after drug administration.	This outcome measure presents area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz).; Time frame note: The time points 72:00h, 96:00h below was only applicable for highest dose (and corresponding placebo subjects).; Two blood sample for stability testing were taken at 3:00h time point from the Treatment C dose group only.; The doses ranged from 10 μg to 3600 μg for the outcome measure \[AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)\].
Cmax (Maximum Measured Concentration of the Analyte in Plasma)	1.30 (hours: minutes) hours (h) before drug administration and 0:05h, 0:10h, 0:15h, 0:20h, 0:30h, 0:40h, 0:50h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h, 96:00h after drug administration.	This outcome measure presents maximum concentration of analyte in plasma (Cmax).; Time frame note: The time points 72:00h, 96:00h below was only applicable for highest dose (and corresponding placebo subjects).; Two blood sample for stability testing were taken at 3:00h time point from the Treatment C dose group only.; The doses ranged from 10 μg to 3600 μg for the outcome measure \[Cmax (maximum measured concentration of the analyte in plasma)\].

Trial Locations

Locations (1)

Humanpharmakologisches Zentrum Biberach; 🇩🇪 Biberach, Germany