Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of BI 113608 in Healthy Male Volunteers - Full Text View

Purpose

The objective of the current trial is to evaluate safety, tolerability and pharmacokinetics of multiple rising doses of BI 113608 in healthy male volunteers

Condition	Intervention	Phase
Healthy	Drug: BI 113608 PIB bid Drug: Placebo to BI 113608 PIB bid Drug: Placebo to BI 113608 PIB qd Drug: BI 113608 PIB qd	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of BI 113608 Powder for Oral Solution in Healthy Male Volunteers q.d. or b.i.d. for 14 Days (a Randomised, Double-blind, Placebo-controlled Within Dose Groups Phase I Trial)

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

Number of participants with adverse events [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
Number of participants with changes from baseline in physical examination including orthostasis test [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
Number of participants with changes from baseline in electrocardiogram (ECG) results [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
Number of participants with significant changes from baseline laboratory measurements [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Cmax,ss (maximum measured concentration of the analyte in plasma at steady state) [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state) [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
t1/2,ss (terminal half-life of the analyte in plasma at steady state) [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
RA,Cmax (Accumulation ratio of the analyte in plasma at steady state after multiple oral administration over a uniform dosing interval t, expressed as ratio of Cmax at steady state and after single dose) [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
RA,AUC (Accumulation ratio of the analyte in plasma at steady state after multiple dose administration over a uniform dosing interval t, expressed as ratio of AUC at steady state and after single dose) [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]

Enrollment:	36
Study Start Date:	September 2012
Study Completion Date:	May 2013
Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: BI 113608 high dose bid powder in the bottle for oral solution, oral administration with 240 ml water	Drug: Placebo to BI 113608 PIB bid powder for oral solution Drug: BI 113608 PIB bid powder for oral solution
Experimental: BI 113608 low dose bid powder in the bottle for oral solution, oral administration with 240 ml water	Drug: Placebo to BI 113608 PIB bid powder for oral solution Drug: BI 113608 PIB bid powder for oral solution
Experimental: BI 113608 medium dose bid powder in the bottle for oral solution, oral administration with 240 ml water	Drug: BI 113608 PIB bid powder for oral solution Drug: Placebo to BI 113608 PIB bid powder for oral solution
Experimental: BI 113608 high dose qd powder in the bottle for oral solution, oral administration with 240 ml water	Drug: Placebo to BI 113608 PIB qd powder for oral solution Drug: BI 113608 PIB qd powder for oral solution

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria:

1. healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01681277

Locations

Germany
1314.2.1 Boehringer Ingelheim Investigational Site
Mannheim, Germany

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01681277 History of Changes
Other Study ID Numbers:	1314.2, 2012-002536-82
Study First Received:	September 5, 2012
Last Updated:	May 15, 2013
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on May 16, 2013