NCT01917916

Brief Summary

Safety, tolerability, pharmacokinetics and pharmacodynamics of BI 655064 after single rising doses in healthy Asian male volunteers.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Aug 2013

Typical duration for phase_1 healthy

Geographic Reach
2 countries

2 active sites

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

August 2, 2013

Completed
3 days until next milestone

Study Start

First participant enrolled

August 5, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2014

Completed
9.2 years until next milestone

Results Posted

Study results publicly available

August 9, 2023

Completed
Last Updated

August 9, 2023

Status Verified

September 1, 2022

Enrollment Period

9 months

First QC Date

August 2, 2013

Results QC Date

September 26, 2022

Last Update Submit

September 26, 2022

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Investigator Defined Drug-related Adverse Events

    Number of participants with investigator defined drug-related adverse events (AEs) is reported.

    From study drug administration until end-of-study examination, up to 77 days.

Secondary Outcomes (3)

  • Maximum Measured Concentration of BI 655064 in Plasma (Cmax)

    Within 3:00 hours:minutes (h:min) before and 08:00h, 12:00h, 24:00h, 36:00h, 48:00h, 72:00h, 96:00h, 108:00h, 120:00h, 168:00h, 264:00h, 432:00h, 648:00h, 984:00h, 1320:00h, 1656:00 h:min after BI 655064 administration.

  • Area Under the Concentration-time Curve of the Analyte BI 655064 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

    Within 3:00 hours:minutes (h:min) before and 08:00h, 12:00h, 24:00h, 36:00h, 48:00h, 72:00h, 96:00h, 108:00h, 120:00h, 168:00h, 264:00h, 432:00h, 648:00h, 984:00h, 1320:00h, 1656:00 h:min after BI 655064 administration.

  • Area Under the Concentration-time Curve of the Analyte BI 655064 in the Plasma Over the Time Interval From 0 to the Last Measurable Time Point (AUC0-tz)

    Within 3:00 hours:minutes (h:min) before and 08:00h, 12:00h, 24:00h, 36:00h, 48:00h, 72:00h, 96:00h, 108:00h, 120:00h, 168:00h, 264:00h, 432:00h, 648:00h, 984:00h, 1320:00h, 1656:00 h:min after BI 655064 administration.

Study Arms (5)

BI 655064 dose group 1 - 80 mg

EXPERIMENTAL
Drug: BI 655064

BI 655064 dose group 2 - 120 mg

EXPERIMENTAL
Drug: BI 655064

BI 655064 dose group 3 - 180 mg

EXPERIMENTAL
Drug: BI 655064

BI 655064 dose group 4 - 240 mg

EXPERIMENTAL
Drug: BI 655064

Placebo matching BI 655064

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PlaceboDRUG

Solution for subcutaneous (s.c.) injection.

Placebo matching BI 655064
BI 655064DRUG

Solution for subcutaneous (s.c.) injection.

BI 655064 dose group 1 - 80 mgBI 655064 dose group 2 - 120 mgBI 655064 dose group 3 - 180 mgBI 655064 dose group 4 - 240 mg

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
  • Chinese ethnicity, Japanese ethnicity according to the following criteria. Japanese: born in Japan, have lived outside of Japan \<10 years, and have parents and grandparents who were all born in Japan. Chinese: ethnic Chinese, born in China or ethnic Chinese born outside of China, and a descendent of 4 ethnic Chinese grandparents who were all born in China
  • Age within the range of 20 to 45 years inclusive
  • Body mass index within the range of 18.5 and 25 kg/m2 inclusive
  • Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.

You may not qualify if:

  • Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
  • Any disease or clinically relevant abnormality in laboratory parameters which, according to the investigator, might compromise the safety of the subject or interfere with the subjects participation in the trial or compromise the trial objectives
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • 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)

1293.8.8101 Boehringer Ingelheim Investigational Site

Sumida-ku,Tokyo, Japan

Location

1293.8.8201 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

Related Links

MeSH Terms

Interventions

BI 655064

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
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2013

First Posted

August 7, 2013

Study Start

August 5, 2013

Primary Completion

May 14, 2014

Study Completion

May 14, 2014

Last Updated

August 9, 2023

Results First Posted

August 9, 2023

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Locations

KR(1)JP(1)