NCT01958060

Brief Summary

Investigation of safety and tolerability of BI 1034020 in healthy male volunteers following intravenous (IV) infusion of subcutaneous (SC) injection of single doses and exploration of the pharmacokinetics and pharmacodynamics of BI 1034020 after single dosing and determination of the bioavailability of subcutaneous injections of BI 1034020

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
35

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Oct 2013

Typical duration for phase_1 healthy

Geographic Reach
1 country

2 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

October 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

July 30, 2015

Completed
Last Updated

July 30, 2015

Status Verified

July 1, 2015

Enrollment Period

6 months

First QC Date

October 1, 2013

Results QC Date

July 2, 2015

Last Update Submit

July 2, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Percentage of Subjects With Drug Related Adverse Events

    Percentage of subjects with investigator defined drug-related adverse events

    from the first drug administration to end of trial, up to 50 days

Secondary Outcomes (3)

  • Cmax

    2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1.

  • AUC0-inf

    2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1.

  • AUC0-tz

    2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1.

Study Arms (2)

BI 1034020 intravenous part

EXPERIMENTAL

single rising doses

Drug: BI 1034020Drug: Placebo to BI 1034020

BI 1034020 subcutaneous part

EXPERIMENTAL

single rising doses

Drug: BI 1034020Drug: Placebo to BI 1034020

Interventions

BI 1034020DRUG

intravenous part

BI 1034020 intravenous partBI 1034020 subcutaneous part
Placebo to BI 1034020DRUG

intravenous part

BI 1034020 intravenous partBI 1034020 subcutaneous part

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males based upon a complete medical history, including a physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests
  • Age within the range of 18 to 40 years
  • Body mass index within the range of 18.5 and 29.9 kg/m2
  • Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.

You may not qualify if:

  • Any finding in the medical examination (including blood pressure, pulse rate or electrocardiogram) deviating from normal and judged clinically relevant by the investigator. Pulse rate outside the range of 50-90 bpm or blood pressure outside the ranges of 90-140 for systolic and 50-90 mmHg for diastolic blood pressure if confirmed by repeat measurement
  • Any evidence of a clinically relevant concomitant disease.
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
  • Surgery of the gastrointestinal tract (except appendectomy).
  • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders.
  • History of relevant orthostatic hypotension, fainting spells or blackouts.
  • Chronic or relevant acute infections.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

1312.1.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Location

1312.1.2 Boehringer Ingelheim Investigational Site

Ingelheim, Germany

Location

Limitations and Caveats

Due to a drug-related Serious Adverse event in the first subject of 100 mg BI 1034020 single iv dose group, the trial was prematurely terminated. No further iv dosing was performed and no planned sc dosing scheme was performed in this trial.

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

October 1, 2013

First Posted

October 8, 2013

Study Start

October 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

July 30, 2015

Results First Posted

July 30, 2015

Record last verified: 2015-07

Locations

DE(2)