Safety Tolerability and Pharmacokinetic of BI 411034

July 5, 2017 updated by: Boehringer Ingelheim

Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 411034 (PIB) in Healthy Male Volunteers (Randomised, Single-blind, Placebocontrolled Within Dose Groups, Phase I Study)

The primary objective of the current study is to investigate the safety, tolerability and pharmacokinetics of BI 411034 in healthy male volunteers following oral administration of single rising doses.

The secondary objective is to explore dose proportionality of BI 411034 in CYP2C19 (Cytochrome P450) genotyped extensive metabolisers (EM).

Another objective is to compare the safety and pharmacokinetic profiles between two different groups of CYP2C19 genotyped subjects, extensive metabolisers (EM) and poor metabolisers (PM)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

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
      • Ingelheim, Germany
        • 1308.1.1 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 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion criteria:

1. Healthy male subjects

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: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Solution for oral administration
Drug: Placebo
Solution for oral administration
Experimental: BI 411034 low dose - group 1
Solution for oral administration
Drug: BI 411034
Low dose solution for oral administration
Drug: BI 411034
Medium dose solution for oral administration
Drug: BI 411034
High dose solution for oral administration
Experimental: BI 411034 low dose - group 2
Solution for oral administration
Drug: BI 411034
Low dose solution for oral administration
Drug: BI 411034
Medium dose solution for oral administration
Drug: BI 411034
High dose solution for oral administration
Experimental: BI 411034 medium dose - group 3
Solution for oral administration
Drug: BI 411034
Low dose solution for oral administration
Drug: BI 411034
Medium dose solution for oral administration
Drug: BI 411034
High dose solution for oral administration
Experimental: BI 411034 medium dose - group 4
Solution for oral administration
Drug: BI 411034
Low dose solution for oral administration
Drug: BI 411034
Medium dose solution for oral administration
Drug: BI 411034
High dose solution for oral administration
Experimental: BI 411034 medium dose - group 5
Solution for oral administration
Drug: BI 411034
Low dose solution for oral administration
Drug: BI 411034
Medium dose solution for oral administration
Drug: BI 411034
High dose solution for oral administration
Experimental: BI 411034 high dose - group 6
Solution for oral administration
Drug: BI 411034
Low dose solution for oral administration
Drug: BI 411034
Medium dose solution for oral administration
Drug: BI 411034
High dose solution for oral administration
Experimental: BI 411034 high dose - group 7
Solution for oral administration
Drug: BI 411034
Low dose solution for oral administration
Drug: BI 411034
Medium dose solution for oral administration
Drug: BI 411034
High dose solution for oral administration
Experimental: BI 411034 high dose - group 8
Solution for oral administration
Drug: BI 411034
Low dose solution for oral administration
Drug: BI 411034
Medium dose solution for oral administration
Drug: BI 411034
High dose solution for oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Drug Related AEs
Time Frame: From drug administration until end of trial examination, up to 13 days
Number of participants with drug related adverse events (AEs)
From drug administration until end of trial examination, up to 13 days
Clinically Relevant Abnormalities for Physical Examinations, Vital Signs, ECG, Laboratory Tests
Time Frame: From drug administration until end of trial examination, up to 13 days
Clinically relevant abnormalities for physical examinations, vital signs (blood pressure, pulse rate, oral body temperature, orthostasis test), 12-lead electrocardiogram (ECG) and clinical laboratory tests. Clinically relevant abnormalities are reported by the investigator as adverse events (AEs).
From drug administration until end of trial examination, up to 13 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Measured Concentration (Cmax )
Time Frame: 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration
Maximum measured concentration of the analyte (BI 411034) in plasma
2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration
Time to Maximum Measured Concentration (Tmax)
Time Frame: 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration
Time from dosing to maximum measured concentration
2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration
Area Under the Curve From 0 Extrapolated to Infinity (AUC0-infinity)
Time Frame: 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration
Area under the concentration-time curve of the analyte (BI 411034) in plasma over the time interval from 0 extrapolated to infinity
2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration
Amount of Analyte Eliminated in Urine From 0h to 4h (Ae0-4)
Time Frame: 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration
Amount of analyte (BI 411034) eliminated in urine from the time point 0h to time point 4h.
2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration

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

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 (Actual)

April 1, 2012

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

April 19, 2012

First Submitted That Met QC Criteria

April 19, 2012

First Posted (Estimate)

April 20, 2012

Study Record Updates

Last Update Posted (Actual)

August 15, 2017

Last Update Submitted That Met QC Criteria

July 5, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 1308.1
  • 2011-004840-23 (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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