Safety and Pharmacokinetics of Multiple Rising Oral Doses of BI 224436 in Healthy Male Volunteers.

Phase 1

Withdrawn

• Conditions: HIV Infections; Healthy
• Interventions: Drug: BI 224436; Drug: Placebo

• Registration Number: NCT01276990
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To investigate the safety and pharmacokinetic of BI 224436 in healthy male volunteers following oral administration of repeated doses for 10 days within 8 dosing regimens.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-13
• Study First Submitted QC: 2011-01-13
• Study First Posted: 2011-01-14
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-08
• Last Update Posted: 2012-02-09
• Primary Completion: 2012-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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 224436 dosing regimen 3	BI 224436	Dosing regimen 3
BI 224436 dosing regimen 4	BI 224436	Dosing regimen 4
BI 224436 dosing regimen 8	BI 224436	Dosing regimen 8
Placebo	Placebo	Matching placebo in dosing regimen 1-8
BI 224436 dosing regimen 1	BI 224436	Dosing regimen 1
BI 224436 dosing regimen 2	BI 224436	Dosing regimen 2
Placebo	BI 224436	Matching placebo in dosing regimen 1-8
BI 224436 dosing regimen 5	BI 224436	Dosing regimen 5
BI 224436 dosing regimen 6	BI 224436	Dosing regimen 6
BI 224436 dosing regimen 7	BI 224436	Dosing regimen 7

Primary Outcome Measures

Name	Time	Method
Changes in blood pressure	1 month
Changes in pulse rate	1 month
Changes in 12-lead ECG	1 month
Changes in clinical laboratory test parameters	1 month
Adverse events	1 month

Secondary Outcome Measures

Name	Time	Method
Cmax,ss (maximum measured concentration of the analyte in plasma at steady-state over a uniform dosing interval t)	10 days
tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady-state)	10 Days
Cmin,ss (minimum concentration of the analyte in plasma at steady-state over a uniform dosing interval t)	10 days
AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady-state over a uniform dosing interval t)	13 days
t1/2,ss (terminal half-life of the analyte in plasma at steady-state)	13 days
CL/F,ss (apparent clearance of the analyte in the plasma at steady-state following extravascular multiple dose administration)	13 days