Multiple Rising Oral Doses of BI 691751 in Healthy Male Subjects

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: BI 691751; Drug: Placebo

• Registration Number: NCT02148107
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

It is the objective of this MRD trial to investigate pharmacokinetics, pharmcodynamics, safety and tolerability of rising doses BI 691751 over a treatment period of 14 days to support the further clinical development of this LTA4H-inhibitor. Special emphasis will be given to detect potential effects of BI 691751 on heart rate.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-19
• Study First Submitted QC: 2014-05-23
• Study First Posted: 2014-05-28
• Primary Completion: 2014-07
• Study Completion: 2014-08
• Results First Submitted: 2015-11-11
• Status Verified: 2016-02
• Results First Submitted QC: 2016-02-01
• Last Update Submitted: 2016-02-01
• Results First Posted: 2016-02-29
• Last Update Posted: 2016-02-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 18

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 691751 Dose 1	BI 691751	multiple dose given over 14 days
BI 691751 Dose 2	BI 691751	multiple dose given over 14 days
BI 691751 Dose 3	BI 691751	multiple dose given over 14 days
BI 691751 Dose 4	BI 691751	multiple dose given over 14 days
BI 691751 Dose 5	BI 691751	multiple dose given over 14 days
BI 691751 Dose 6	BI 691751	multiple dose given over 14 days
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Drug-related Adverse Events	From the time of administration of the respective treatment until 21 days after last administration of study drug or start of the post-study phase to the respective treatment, up to 35 days	Percentage of subjects with drug-related Adverse events (AEs)

Secondary Outcome Measures

Name	Time	Method
AUCt,1 (Area Under the Concentration-time Curve of the Analyte in Plasma Over a Uniform Dosing Interval t After Administration of the First Dose)	0 minutes (min), 10min, 20min, 40min, 1 hour (h), 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24h after first drug administration	AUCt,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t after administration of the first dose).; This endpoint could not be calculated as no PK blood samples were analysed due to the early termination of the study.
Cmax (Maximum Measured Concentration of the Analyte Inplasma)	0 minutes (min), 10min, 20min, 40min, 1 hour (h), 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24h after first drug administration	Cmax (maximum measured concentration of the analyte inplasma).; This endpoint could not be calculated as no PK blood samples were analysed due to the early termination of the study.
AUCt,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t)	312 hours (h), 312 h 10 minutes (min), 312h 20min, 312h 40min, 313, 313h 30min, 314h, 315h, 316h, 318h, 320h, 322h, 324h and 336h after first drug administration	AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t).; This endpoint could not be calculated as no PK blood samples were analysed due to the early termination of the study.
Cmax,ss (Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t)	312 hours (h), 312 h 10 minutes (min), 312h 20min, 312h 40min, 313, 313h 30min, 314h, 315h, 316h, 318h, 320h, 322h, 324h and 336h after first drug administration	Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t).; This endpoint could not be calculated as no PK blood samples were analysed due to the early termination of the study.

Trial Locations

Locations (1)

1334.2.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Berlin, Germany