NCT01650155

Brief Summary

To investigate the safety and tolerability of BI 1005273 in healthy male volunteers following intravenous (i.v.) infusion of single rising doses and subcutaneous (s.c.) injection. Secondary objectives are the exploration of the pharmacokinetics and early pharmacodynamics of BI 1005273.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jul 2012

Longer than 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

July 1, 2012

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 26, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

October 16, 2014

Status Verified

October 1, 2014

Enrollment Period

2.2 years

First QC Date

July 18, 2012

Last Update Submit

October 14, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • number (% subjects) with drug-related AEs.

    day -21 to day 95

Secondary Outcomes (3)

  • Cmax (maximum measured concentration of the analyte in plasma)

    day 1 to day 90

  • AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

    day 1 to day 90

  • AUC0-tz (area under the concentration-time curve of the analyte in the plasma over the time interval from 0 to the last measurable time point of the dose)

    day 1 to day 90

Study Arms (4)

BI 1005273 i.v.

EXPERIMENTAL

single dose i.v. infusion

Drug: BI 1005273 i.v.

BI 1005273 i.v. Placebo

PLACEBO COMPARATOR

single dose i.v. infusion (Placebo)

Drug: BI 105273 i.v. Placebo

BI 1005273 s.c.

EXPERIMENTAL

single dose s.c. injection

Drug: BI 1005273 s.c.

BI 1005273 s.c. Placebo

PLACEBO COMPARATOR

single dose s.c. injection (Placebo)

Drug: BI 1005273 s.c. Placebo

Interventions

BI 1005273 s.c.DRUG

injection

BI 1005273 s.c.
BI 105273 i.v. PlaceboDRUG

infusion

BI 1005273 i.v. Placebo
BI 1005273 s.c. PlaceboDRUG

injection

BI 1005273 s.c. Placebo
BI 1005273 i.v.DRUG

infusion

BI 1005273 i.v.

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 deviation from healthy conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1294.1.1 Boehringer Ingelheim Investigational Site

Berlin, 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
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2012

First Posted

July 26, 2012

Study Start

July 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

October 16, 2014

Record last verified: 2014-10

Locations

DE(1)