Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 691751 in Healthy Asian Male Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo to BI 691751; Drug: BI 691751 middle dose; Drug: BI 691751 low dose 2; Drug: BI 691751 low dose 1; Drug: BI 691751 high dose

• Registration Number: NCT02057835
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-06
• Study First Submitted QC: 2014-02-06
• Study First Posted: 2014-02-07
• Study Start: 2014-03
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2015-11
• Results First Submitted: 2015-11-11
• Results First Submitted QC: 2015-11-11
• Last Update Submitted: 2015-11-11
• Results First Posted: 2015-12-16
• Last Update Posted: 2015-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 64

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 691751 low dose 2	BI 691751 low dose 2	BI 691751 low dose 2
BI 691751 low dose 2	Placebo to BI 691751	BI 691751 low dose 2
BI 691751 low dose 1	Placebo to BI 691751	BI 691751 low dose 1
BI 691751 low dose 1	BI 691751 low dose 1	BI 691751 low dose 1
BI 691751 middle dose	BI 691751 middle dose	BI 691751 middle dose
BI 691751 middle dose	Placebo to BI 691751	BI 691751 middle dose
BI 691751 high dose	Placebo to BI 691751	BI 691751 high dose
BI 691751 high dose	BI 691751 high dose	BI 691751 high dose

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Drug Related Adverse Events	From drug administration until 31 days after drug administration, 31 days	Percentage of participants with drug related adverse events (AEs)

Secondary Outcome Measures

Name	Time	Method
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 in plasma/whole blood
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 (last) dosing to the maximum measured concentration of the analyte in plasma/whole blood
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	Maximum measured concentration of the analyte in plasma/whole blood for all participants (Chinese and Japanese)
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	Time from (last) dosing to the maximum measured concentration of the analyte in plasma/whole blood for all participants (Chinese and Japanese)
Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz)	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 in plasma/whole blood over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz)
Terminal Half-life of the Analyte (T1/2)	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	Terminal half-life (T1/2) of the analyte in plasma/whole blood
Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity) - 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 in plasma/whole blood over the time interval from 0 extrapolated to infinity for all participants (Chinese and Japanese)
Terminal Half-life of the Analyte (T1/2) - 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	Terminal half-life (T1/2) of the analyte in plasma/whole blood for all participants (Chinese and Japanese)
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	Area under the concentration-time curve of the analyte in plasma/whole blood over the time interval from 0 extrapolated to infinity (AUC0-infinity)
Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz) - 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 in plasma/whole blood over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz) for all participants (Chinese and Japanese)

Trial Locations

Locations (1)

1334.5.82001 Boehringer Ingelheim Investigational Site; 🇰🇷 Seoul, Korea, Republic of