NCT01541488

Brief Summary

Safety, tolerability, pharmacokinetics and early pharmacodynamics of single rising oral doses of BI 1021958 tablets in healthy male volunteers (first-in-human trial)

Trial Health

80
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P75+ for phase_1 healthy

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

February 1, 2012

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Last Updated

October 31, 2013

Status Verified

October 1, 2013

Enrollment Period

3 months

First QC Date

February 22, 2012

Last Update Submit

October 30, 2013

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

  • Number of participants with clinically relevant findings in physical examination

    up to 14 days postdose

  • Number of participants with clinically relevant findings in vital signs

    up to 14 days postdose

  • Number of participants with clinically significant abnormalities in electrocardiogram (ECG) results

    up to 14 days postdose

  • Number of participants with significant changes from baseline laboratory measurements

    up to 14 days postdose

  • Number of participants with adverse events

    up to 14 days postdose

  • Assessment of tolerability by investigator

    up to 14 days postdose

Secondary Outcomes (3)

  • Cmax (maximum measured concentration of BI 1021958 in plasma)

    up to 72h postdose

  • area under the concentration-time curve of BI 1021958 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)

    up to 72h postdose

  • AUC0-tz (area under the concentration-time curve of BI 1021958 in plasma over the time interval from 0 up to the last quantifiable data point)

    up to 72h postdose

Study Arms (3)

BI 1021958

EXPERIMENTAL

Single rising dose (SRD) part

Drug: BI 1021958

BI 1021958 (Food effect)

EXPERIMENTAL

Food effect part (FE)

Drug: BI 1021958

Placebo to BI 1021958

PLACEBO COMPARATOR

Matching placebo as drinking solution and tablets

Drug: Placebo to BI 1021958

Interventions

BI 1021958DRUG

tablet

BI 1021958 (Food effect)
Placebo to BI 1021958DRUG

SRD part: oral administration in fasted state, FE part: oral administration in fasted state and after standard high fat breakfast

Placebo to BI 1021958

Eligibility Criteria

Age18 Years - 45 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)

1310.1.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Location

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

February 22, 2012

First Posted

March 1, 2012

Study Start

February 1, 2012

Primary Completion

May 1, 2012

Last Updated

October 31, 2013

Record last verified: 2013-10

Locations

DE(1)