To Investigate the Safety, Tolerability, Pharmacokinetics and the Relative Bioavailability of BI 1026706

This study is currently recruiting participants.

Verified June 2013 by Boehringer Ingelheim Pharmaceuticals

Sponsor:

Information provided by (Responsible Party):

Boehringer Ingelheim Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01763333

First received: January 7, 2013

Last updated: June 13, 2013

Last verified: June 2013

Purpose

To investigate the safety, tolerability, pharmacokinetics and the relative bioavailability of BI 1026706

Condition	Intervention	Phase
Healthy	Drug: BI 1026706 Placebo Drug: BI 1026706	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Single Blind Primary Purpose: Treatment
Official Title:	Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1026706 in Healthy Male Volunteers in a Partially Randomised, Single-blind, Placebo-controlled Trial, and Investigation of Relative Bioavailability of BI 1026706 (Open-label, Randomised, Three-way Cross-over)

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

Number of subjects (%) with drug related adverse events (AEs) [ Time Frame: up to 72 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 72 hours ] [ Designated as safety issue: No ]
tmax (time from dosing to maximum measured concentration) [ Time Frame: up to 72 hours ] [ Designated as safety issue: No ]
AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: up to 72 hours ] [ Designated as safety issue: No ]
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point) [ Time Frame: up to 72 hours ] [ Designated as safety issue: No ]
t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: up to 72 hours ] [ Designated as safety issue: No ]
fet1-t2 (fraction of analyte eliminated in urine from the time point t1 to time point t2) [ Time Frame: up to 72 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	68
Study Start Date:	January 2013
Estimated Study Completion Date:	August 2013
Estimated Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 BI 1026706 single rising dose part single rising doses of BI 1026706	Drug: BI 1026706 Placebo Placebo to BI 1026706 Drug: BI 1026706 single dose (low to high dose)
Experimental: 2 BI 1026706 bioavailability part bioavailability part of BI 1026706	Drug: BI 1026706 different dose formulations

Eligibility

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: NCT01763333

Contacts

Contact: Boehringer Ingelheim Call Center

1-800-243-0127

Locations

Germany
1320.1.1 Boehringer Ingelheim Investigational Site	Recruiting
Ingelheim, 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:	NCT01763333 History of Changes
Other Study ID Numbers:	1320.1, 2012-002366-12
Study First Received:	January 7, 2013
Last Updated:	June 13, 2013
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on June 18, 2013