NCT02696616

Brief Summary

Investigation of safety and tolerability of BI 655088 following intravenous infusion of single rising doses and exploration of the pharmacokinetics and pharmacodynamics of BI 655088 after single dosing

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Mar 2016

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

First Submitted

Initial submission to the registry

February 26, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 2, 2016

Completed
14 days until next milestone

Study Start

First participant enrolled

March 16, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2019

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

January 25, 2023

Completed
Last Updated

January 25, 2023

Status Verified

April 1, 2022

Enrollment Period

2.9 years

First QC Date

February 26, 2016

Results QC Date

April 20, 2022

Last Update Submit

April 20, 2022

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects With Drug-related Adverse Events

    The number of subjects with drug-related adverse events.

    up to 99 days after start of drug administration

Secondary Outcomes (3)

  • Maximum Measured Concentration of BI 655088 in Plasma (Cmax)

    Up to 2016 hours. See endpoint description for a detailed timeframe.

  • Area Under the Concentration-time Curve of BI 655088 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

    Up to 2016 hours. See endpoint description for a detailed timeframe.

  • Area Under the Concentration-time Curve of BI 655088 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)

    Up to 2016 hours. See endpoint description for a detailed timeframe.

Study Arms (2)

BI 655088

EXPERIMENTAL
Drug: BI 655088

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

BI 655088DRUG
BI 655088
PlaceboDRUG
Placebo

Eligibility Criteria

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

You may qualify if:

  • Healthy male subjects
  • Age of 18 to 50 years
  • Body mass index (BMI) of 18.5 to 29.9 kg/m2

You may not qualify if:

  • Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged as clinically relevant by the investigator
  • Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg or diastolic blood pressure outside the range of 50 to 90 mmHg or pulse rate outside the range of 45 to 90 bpm
  • Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
  • Any evidence of a concomitant disease judged as clinically relevant by the investigator
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Diseases of the central nervous system (including but not limited to any kind of seizures and stroke), and other relevant neurological disorders or psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SGS Life Science Services - Clinical Research

Edegem, 2650, Belgium

Location

Related Links

Results Point of Contact

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

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

February 26, 2016

First Posted

March 2, 2016

Study Start

March 16, 2016

Primary Completion

February 14, 2019

Study Completion

February 14, 2019

Last Updated

January 25, 2023

Results First Posted

January 25, 2023

Record last verified: 2022-04

Locations

BE(1)