Safety Tolerability and Pharmacokinetic of BI 411034

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 411034; Drug: Placebo

• Registration Number: NCT01581684
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The primary objective of the current study is to investigate the safety, tolerability and pharmacokinetics of BI 411034 in healthy male volunteers following oral administration of single rising doses.

The secondary objective is to explore dose proportionality of BI 411034 in CYP2C19 (Cytochrome P450) genotyped extensive metabolisers (EM).

Another objective is to compare the safety and pharmacokinetic profiles between two different groups of CYP2C19 genotyped subjects, extensive metabolisers (EM) and poor metabolisers (PM)

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-01
• Study First Submitted: 2012-04-19
• Study First Submitted QC: 2012-04-19
• Study First Posted: 2012-04-20
• Primary Completion: 2012-08-01
• Study Completion: 2012-08-01
• Results First Submitted: 2014-03-13
• Results First Submitted QC: 2014-03-13
• Results First Posted: 2014-04-17
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-05
• Last Update Posted: 2017-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 62

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BI 411034 medium dose - group 4	BI 411034	Solution for oral administration
BI 411034 high dose - group 7	BI 411034	Solution for oral administration
BI 411034 medium dose - group 5	BI 411034	Solution for oral administration
BI 411034 high dose - group 8	BI 411034	Solution for oral administration
Placebo	Placebo	Solution for oral administration
BI 411034 low dose - group 1	BI 411034	Solution for oral administration
BI 411034 low dose - group 2	BI 411034	Solution for oral administration
BI 411034 medium dose - group 3	BI 411034	Solution for oral administration
BI 411034 high dose - group 6	BI 411034	Solution for oral administration

Primary Outcome Measures

Name	Time	Method
Number of Participants With Drug Related AEs	From drug administration until end of trial examination, up to 13 days	Number of participants with drug related adverse events (AEs)
Clinically Relevant Abnormalities for Physical Examinations, Vital Signs, ECG, Laboratory Tests	From drug administration until end of trial examination, up to 13 days	Clinically relevant abnormalities for physical examinations, vital signs (blood pressure, pulse rate, oral body temperature, orthostasis test), 12-lead electrocardiogram (ECG) and clinical laboratory tests. Clinically relevant abnormalities are reported by the investigator as adverse events (AEs).

Secondary Outcome Measures

Name	Time	Method
Maximum Measured Concentration (Cmax )	2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration	Maximum measured concentration of the analyte (BI 411034) in plasma
Time to Maximum Measured Concentration (Tmax)	2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration	Time from dosing to maximum measured concentration
Area Under the Curve From 0 Extrapolated to Infinity (AUC0-infinity)	2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration	Area under the concentration-time curve of the analyte (BI 411034) in plasma over the time interval from 0 extrapolated to infinity
Amount of Analyte Eliminated in Urine From 0h to 4h (Ae0-4)	2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration	Amount of analyte (BI 411034) eliminated in urine from the time point 0h to time point 4h.

Trial Locations

Locations (1)

1308.1.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Ingelheim, Germany