A Study to Test How Food Influences the Amount of BI 1323495 in the Blood of Healthy Men

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 1323495,

• Registration Number: NCT03802331
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The main objective of this trial is to assess the effect of food on the pharmacokinetics of an oral tablet formulation of BI 1323495 by investigating the relative bioavailability following single dose administration under fed and fasted conditions.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-01-10
• Study First Submitted QC: 2019-01-10
• Study First Posted: 2019-01-14
• Study Start: 2019-01-28
• Primary Completion: 2019-03-03
• Study Completion: 2019-03-03
• Status Verified: 2023-07
• Results First Submitted: 2023-07-07
• Results First Submitted QC: 2023-07-07
• Last Update Submitted: 2023-07-07
• Results First Posted: 2024-02-22
• Last Update Posted: 2024-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Reference Treatment	BI 1323495,	fasted
Test Treatment	BI 1323495,	fed

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration-time Curve of BI 1323495 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point	Within 2 hours before and then 20 minutes (min), 40 min, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 34, 48, 72 and 96 hours after drug administration	Area under the concentration-time curve of BI 1323495 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).; The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for sequence, subjects nested within sequences, period, and treatment. Confidence intervals were calculated based on the residual error from the ANOVA.
Maximum Measured Concentration of BI 1323495 in Plasma	Within 2 hours before and then 20 minutes (min), 40 min, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 34, 48, 72 and 96 hours after drug administration	Maximum measured concentration of BI 1323495 in plasma (Cmax).; The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for sequence, subjects nested within sequences, period, and treatment. Confidence intervals were calculated based on the residual error from the ANOVA.

Secondary Outcome Measures

Name	Time	Method
Area Under the Concentration-time Curve of BI 1323495 in Plasma Over the Time Interval From 0 Extrapolated to Infinity	Within 2 hours before and then 20 minutes (min), 40 min, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 34, 48, 72 and 96 hours after drug administration	Area under the concentration-time curve of BI 1323495 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).; The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for sequence, subjects nested within sequences, period, and treatment. Confidence intervals were calculated based on the residual error from the ANOVA.

Trial Locations

Locations (1)

Humanpharmakologisches Zentrum Biberach; 🇩🇪 Biberach, Germany