NCT02057835

Brief Summary

BI 691751 is currently being developed to inhibit growth and prevent rupture of atherosclerotic plaques and to consequently reduce the risk of major cardiovascular events in patients with established atherosclerotic disease. 1334.5 is a Pan Asian Phase 1 study to investigate safety, tolerability and pharmacokinetics of BI 691751 in healthy Chinese and Japanese male volunteers.

Trial Health

87
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 Mar 2014

Shorter than P25 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 6, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 7, 2014

Completed
22 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

December 16, 2015

Completed
Last Updated

December 16, 2015

Status Verified

November 1, 2015

Enrollment Period

2 months

First QC Date

February 6, 2014

Results QC Date

November 11, 2015

Last Update Submit

November 11, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Drug Related Adverse Events

    Percentage of participants with drug related adverse events (AEs)

    From drug administration until 31 days after drug administration, 31 days

Secondary Outcomes (10)

  • Maximum Measured Concentration of the Analyte (Cmax)

    1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration

  • Maximum Measured Concentration of the Analyte (Cmax) - Overall

    1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration

  • Time From Dosing to the Maximum Measured Concentration of the Analyte (Tmax)

    1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration

  • Time From Dosing to the Maximum Measured Concentration of the Analyte (Tmax) - Overall

    1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration

  • Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity)

    1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration

  • +5 more secondary outcomes

Study Arms (4)

BI 691751 low dose 1

EXPERIMENTAL

BI 691751 low dose 1

Drug: Placebo to BI 691751Drug: BI 691751 low dose 1

BI 691751 low dose 2

EXPERIMENTAL

BI 691751 low dose 2

Drug: Placebo to BI 691751Drug: BI 691751 low dose 2

BI 691751 middle dose

EXPERIMENTAL

BI 691751 middle dose

Drug: BI 691751 middle doseDrug: Placebo to BI 691751

BI 691751 high dose

EXPERIMENTAL

BI 691751 high dose

Drug: Placebo to BI 691751Drug: BI 691751 high dose

Interventions

Placebo to BI 691751DRUG

Placebo to BI 691751

BI 691751 high dose
BI 691751 high doseDRUG

BI 691751 high dose

BI 691751 high dose
BI 691751 middle doseDRUG

BI 691751 middle dose

BI 691751 middle dose
BI 691751 low dose 1DRUG

BI 691751 low dose 1

BI 691751 low dose 1
BI 691751 low dose 2DRUG

BI 691751 low dose 2

BI 691751 low dose 2

Eligibility Criteria

Age18 Years - 45 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 ECG, and clinical laboratory tests
  • Chinese ethnicity, Japanese ethnicity according to the following criteria:
  • 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 Japanese; born in Japan and holding Japanese passport, have lived outside of Japan \<10 years, and have parents and grandparents who were all born in Japan
  • Age within the range of 20 to 45 years
  • Body mass index within the range of 18.5 and 25 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 BP, PR or ECG) 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 laboratory value outside the reference range that the investigator considers to be of clinical relevance
  • Any evidence of a concomitant disease judged clinically relevant by the investigator
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug
  • Diseases of the central nervous system (such as epilepsy), central neurological disorders or psychiatric disorders
  • History of relevant orthostatic hypotension, fainting spells, or blackouts
  • Relevant chronic or acute infections
  • History of relevant allergy/hypersensitivity (including allergy to the trial medication or its excipients)
  • Intake of drugs with a long half-life (greater than 24 hours) within 30 days or less than 10 half-lives of the respective drug prior to study drug administration
  • Use of drugs that might reasonably influence the results of the trial or that might prolong the QT/QTc interval within 14 days prior to study drug administration
  • Participation in another trial with investigational drug administration within 60 days prior to administration of trial medication
  • Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)
  • Inability to refrain from smoking on specified trial days
  • Alcohol abuse (consumption of more than30 g/day)
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1334.5.82001 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

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
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2014

First Posted

February 7, 2014

Study Start

March 1, 2014

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

December 16, 2015

Results First Posted

December 16, 2015

Record last verified: 2015-11

Locations

KR(1)