NCT01581684

Brief Summary

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 20, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

April 17, 2014

Completed
Last Updated

August 15, 2017

Status Verified

July 1, 2017

Enrollment Period

4 months

First QC Date

April 19, 2012

Results QC Date

March 13, 2014

Last Update Submit

July 5, 2017

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Number of Participants With Drug Related AEs

    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

    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 Outcomes (4)

  • Maximum Measured Concentration (Cmax )

    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)

    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)

    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)

    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

Study Arms (9)

BI 411034 low dose - group 1

EXPERIMENTAL

Solution for oral administration

Drug: BI 411034

BI 411034 low dose - group 2

EXPERIMENTAL

Solution for oral administration

Drug: BI 411034

BI 411034 medium dose - group 3

EXPERIMENTAL

Solution for oral administration

Drug: BI 411034

BI 411034 medium dose - group 4

EXPERIMENTAL

Solution for oral administration

Drug: BI 411034

BI 411034 medium dose - group 5

EXPERIMENTAL

Solution for oral administration

Drug: BI 411034

BI 411034 high dose - group 6

EXPERIMENTAL

Solution for oral administration

Drug: BI 411034

BI 411034 high dose - group 7

EXPERIMENTAL

Solution for oral administration

Drug: BI 411034

BI 411034 high dose - group 8

EXPERIMENTAL

Solution for oral administration

Drug: BI 411034

Placebo

PLACEBO COMPARATOR

Solution for oral administration

Drug: Placebo

Interventions

BI 411034DRUG

Low dose solution for oral administration

BI 411034 low dose - group 2
PlaceboDRUG

Solution for oral administration

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \. Healthy male subjects

You may not qualify if:

  • \. Any relevant deviation from healthy conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1308.1.1 Boehringer Ingelheim Investigational Site

Ingelheim, Germany

Location

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim Pharmaceuticals
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2012

First Posted

April 20, 2012

Study Start

April 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

August 15, 2017

Results First Posted

April 17, 2014

Record last verified: 2017-07

Locations

DE(1)