Single Rising Dose Study With Intravenous Infusion and Subcutaneous Injection of BI 1005273 in Healthy Male Volunteers.

Safety, Tolerability, Pharmacokinetics and Early Pharmacodynamics of Single Rising Intravenous and Subcutaneous Doses of BI 1005273 in Healthy Male Volunteers (Randomised, Single-blind, Placebo-controlled Within Dose Groups, Clinical Phase I Study)

To investigate the safety and tolerability of BI 1005273 in healthy male volunteers following intravenous (i.v.) infusion of single rising doses and subcutaneous (s.c.) injection. Secondary objectives are the exploration of the pharmacokinetics and early pharmacodynamics of BI 1005273.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: BI 1005273 i.v.; Drug: BI 105273 i.v. Placebo; Drug: BI 1005273 s.c.; Drug: BI 1005273 s.c. Placebo

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • 1294.1.1 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion criteria:

1. Healthy male subjects

Exclusion criteria:

1. Any deviation from healthy conditions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BI 1005273 i.v.; single dose i.v. infusion	Drug: BI 1005273 i.v.; infusion
Placebo Comparator: BI 1005273 i.v. Placebo; single dose i.v. infusion (Placebo)	Drug: BI 105273 i.v. Placebo; infusion
Experimental: BI 1005273 s.c.; single dose s.c. injection	Drug: BI 1005273 s.c.; injection
Placebo Comparator: BI 1005273 s.c. Placebo; single dose s.c. injection (Placebo)	Drug: BI 1005273 s.c. Placebo; injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
number (% subjects) with drug-related AEs.	day -21 to day 95

Secondary Outcome Measures

Outcome Measure	Time Frame
Cmax (maximum measured concentration of the analyte in plasma)	day 1 to day 90
AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)	day 1 to day 90
AUC0-tz (area under the concentration-time curve of the analyte in the plasma over the time interval from 0 to the last measurable time point of the dose)	day 1 to day 90

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: July 18, 2012
• First Submitted That Met QC Criteria: July 25, 2012
• First Posted (Estimate): July 26, 2012

Study Record Updates

• Last Update Posted (Estimate): October 16, 2014
• Last Update Submitted That Met QC Criteria: October 14, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 1294.1; 2011-004987-30 (EudraCT Number: EudraCT)