Safety of Single Rising Doses and Relative Bioavailability of BI 691751

May 17, 2016 updated by: Boehringer Ingelheim

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Oral Doses of BI 691751 in Healthy Male Volunteers in a Randomised, Single-blind, Placebo-controlled Design (Part I) and Investigation of Relative Bioavailability of BI 691751 Given as Tablet and Oral Solution to Healthy Male Subjects in an Open, Randomised, Single-dose, Single Period Parallel Group Design (Part II).

To investigate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of single rising doses of BI 691751 in healthy male subjects (part I).

To investigate the relative bioavailability of BI 691751 given as tablet versus oral solution (part II)

Study Overview

Status

Completed

Conditions

Healthy

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- - Biberach, Germany
    - 1334.1.1 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion criteria:

Healthy male subjects
Subjects must be able to understand and comply with study requirements
Age from 18 to 55 years
BMI range: from 18.5 to 29.9 kg/m2
Known genotype as specified in the study protocol

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BI 691751 dose 2 (part I) single dose given as oral solution	Drug: BI 691751 oral solution BI 691751, dose 6 Drug: BI 691751 oral solution Drug: BI 691751 oral solution BI 691751, dose 2 Drug: BI 691751 oral solution BI 691751, dose 5 Drug: BI 691751 1 tablet Drug: BI 691751 oral solution BI 691751, dose 3 Drug: BI 691751 oral solution BI 69175, dose 4 Drug: BI 691751 oral solution BI 691751, dose 7 Drug: BI 691751 oral solution BI 69175, dose 1
Experimental: BI 691751 dose 3 (part I) single dose given as oral solution	Drug: BI 691751 oral solution BI 691751, dose 6 Drug: BI 691751 oral solution Drug: BI 691751 oral solution BI 691751, dose 2 Drug: BI 691751 oral solution BI 691751, dose 5 Drug: BI 691751 1 tablet Drug: BI 691751 oral solution BI 691751, dose 3 Drug: BI 691751 oral solution BI 69175, dose 4 Drug: BI 691751 oral solution BI 691751, dose 7 Drug: BI 691751 oral solution BI 69175, dose 1
Experimental: BI 691751 dose 4 (part I) single dose given as oral solution	Drug: BI 691751 oral solution BI 691751, dose 6 Drug: BI 691751 oral solution Drug: BI 691751 oral solution BI 691751, dose 2 Drug: BI 691751 oral solution BI 691751, dose 5 Drug: BI 691751 1 tablet Drug: BI 691751 oral solution BI 691751, dose 3 Drug: BI 691751 oral solution BI 69175, dose 4 Drug: BI 691751 oral solution BI 691751, dose 7 Drug: BI 691751 oral solution BI 69175, dose 1
Experimental: BI 691751 dose 5 (part I) single dose given as oral solution	Drug: BI 691751 oral solution BI 691751, dose 6 Drug: BI 691751 oral solution Drug: BI 691751 oral solution BI 691751, dose 2 Drug: BI 691751 oral solution BI 691751, dose 5 Drug: BI 691751 1 tablet Drug: BI 691751 oral solution BI 691751, dose 3 Drug: BI 691751 oral solution BI 69175, dose 4 Drug: BI 691751 oral solution BI 691751, dose 7 Drug: BI 691751 oral solution BI 69175, dose 1
Experimental: BI 691751 dose 6 (part I) single dose given as oral solution	Drug: BI 691751 oral solution BI 691751, dose 6 Drug: BI 691751 oral solution Drug: BI 691751 oral solution BI 691751, dose 2 Drug: BI 691751 oral solution BI 691751, dose 5 Drug: BI 691751 1 tablet Drug: BI 691751 oral solution BI 691751, dose 3 Drug: BI 691751 oral solution BI 69175, dose 4 Drug: BI 691751 oral solution BI 691751, dose 7 Drug: BI 691751 oral solution BI 69175, dose 1
Experimental: BI 691751 dose 7 (part I) single dose given as oral solution	Drug: BI 691751 oral solution BI 691751, dose 6 Drug: BI 691751 oral solution Drug: BI 691751 oral solution BI 691751, dose 2 Drug: BI 691751 oral solution BI 691751, dose 5 Drug: BI 691751 1 tablet Drug: BI 691751 oral solution BI 691751, dose 3 Drug: BI 691751 oral solution BI 69175, dose 4 Drug: BI 691751 oral solution BI 691751, dose 7 Drug: BI 691751 oral solution BI 69175, dose 1
Experimental: BI 691751dose 1 (part I) single dose given as oral solution	Drug: BI 691751 oral solution BI 691751, dose 6 Drug: BI 691751 oral solution Drug: BI 691751 oral solution BI 691751, dose 2 Drug: BI 691751 oral solution BI 691751, dose 5 Drug: BI 691751 1 tablet Drug: BI 691751 oral solution BI 691751, dose 3 Drug: BI 691751 oral solution BI 69175, dose 4 Drug: BI 691751 oral solution BI 691751, dose 7 Drug: BI 691751 oral solution BI 69175, dose 1
Placebo Comparator: Placebo (part I) placebo solution	Drug: Placebo placebo solution
Experimental: BI 691751 tablet (part II) single dose given as 1 tablet	Drug: BI 691751 oral solution BI 691751, dose 6 Drug: BI 691751 oral solution Drug: BI 691751 oral solution BI 691751, dose 2 Drug: BI 691751 oral solution BI 691751, dose 5 Drug: BI 691751 1 tablet Drug: BI 691751 oral solution BI 691751, dose 3 Drug: BI 691751 oral solution BI 69175, dose 4 Drug: BI 691751 oral solution BI 691751, dose 7 Drug: BI 691751 oral solution BI 69175, dose 1
Active Comparator: BI 691751 solution (part II) single dose given as oral solution	Drug: BI 691751 oral solution BI 691751, dose 6 Drug: BI 691751 oral solution Drug: BI 691751 oral solution BI 691751, dose 2 Drug: BI 691751 oral solution BI 691751, dose 5 Drug: BI 691751 1 tablet Drug: BI 691751 oral solution BI 691751, dose 3 Drug: BI 691751 oral solution BI 69175, dose 4 Drug: BI 691751 oral solution BI 691751, dose 7 Drug: BI 691751 oral solution BI 69175, dose 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-72h (Part II) Time Frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h and 72h after drug administration	AUC0-72h (area under the concentration-time curve of the analyte of BI 691751 in plasma over the time interval from 0 to 72 h) (part II). PPS-BA included all subjects in the TS who were randomised to the BA part, who provided at least one observation for at least one primary endpoint, had no important protocol violations relevant for the statistical evaluation of BA and did not experience emesis at or before twice the median tmax.	1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h and 72h after drug administration
Cmax (Part II) Time Frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug administration	Cmax (maximum measured concentration of the analyte of BI 691751 in plasma) (part II)	1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug administration
Frequency of Subjects With Drug-related Adverse Events (Part I) Time Frame: Part I: 'Day1 to Day21 for Dose 1, 2,3 &4 and Day1 to Day45 for Dose group 5,6 & 7	Frequency of subjects with drug-related Adverse Events (AEs) (Part I)	Part I: 'Day1 to Day21 for Dose 1, 2,3 &4 and Day1 to Day45 for Dose group 5,6 & 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax (Part I) Time Frame: for dose 1 & 2: up to 168h, for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h	Cmax (maximum measured concentration of BI 691751 in plasma) (part I) Time frame: Dose 1 and 2: 1 hour (h) before drug administration (admin) and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h and 168h after drug admin Dose 3 and 4: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h (dose group 4 only), 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h and 240h after drug admin Dose 5 to 7: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 336h, 432h, 528h, 624h and 720h after drug admin Dose 8: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug admin	for dose 1 & 2: up to 168h, for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h
AUC0-infinity (Part I) Time Frame: for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h	AUC0-infinity (area under the concentration-time curve of BI 691751 in plasma over the time interval from 0 extrapolated to infinity) (part I) Time frame: Dose 1 and 2: 1 hour (h) before drug administration (admin) and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h and 168h after drug admin Dose 3 and 4: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h (dose group 4 only), 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h and 240h after drug admin Dose 5 to 7: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 336h, 432h, 528h, 624h and 720h after drug admin Dose 8: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug admin	for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h
AUC0-tz Time Frame: Part 1: for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 7: up to 720h; Part 2: up to 720h	AUC0-tz (area under the concentration-time curve of BI 691751 in plasma over the time interval from 0 up to the last quantifiable data point) (Part I and Part II) Time frame: Dose 1 and 2: 1 hour (h) before drug administration (admin) and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h and 168h after drug admin Dose 3 and 4: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h (dose group 4 only), 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h and 240h after drug admin Dose 5 to 7: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 336h, 432h, 528h, 624h and 720h after drug admin Dose 8: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug admin	Part 1: for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 7: up to 720h; Part 2: up to 720h
t1/2 (Part I) Time Frame: for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h	t1/2 (terminal half-life of the analyte of BI 691751 in plasma) (part I) Time frame: Dose 1 and 2: 1 hour (h) before drug administration (admin) and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h and 168h after drug admin Dose 3 and 4: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h (dose group 4 only), 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h and 240h after drug admin Dose 5 to 7: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 336h, 432h, 528h, 624h and 720h after drug admin Dose 8: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug admin	for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h
Tmax (Part I) Time Frame: for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h	tmax (time from dosing to maximum measured concentration of BI 691751) (part I) Time frame: Dose 1 and 2: 1 hour (h) before drug administration (admin) and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h and 168h after drug admin Dose 3 and 4: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h (dose group 4 only), 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h and 240h after drug admin Dose 5 to 7: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 336h, 432h, 528h, 624h and 720h after drug admin Dose 8: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug admin	for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Related Info

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

April 29, 2013

First Submitted That Met QC Criteria

April 29, 2013

First Posted (Estimate)

May 1, 2013

Study Record Updates

Last Update Posted (Estimate)

June 27, 2016

Last Update Submitted That Met QC Criteria

May 17, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

1334.1
2012-005721-67 (EudraCT Number: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Safety of Single Rising Doses and Relative Bioavailability of BI 691751

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Other Study ID Numbers

Clinical Trials on Healthy

Clinical Trials on Placebo

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