Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of BI 113608 in Healthy Male Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01681277
First received: September 5, 2012
Last updated: July 10, 2013
Last verified: July 2013
  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:

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: 48
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01681277     History of Changes
Other Study ID Numbers: 1314.2, 2012-002536-82
Study First Received: September 5, 2012
Last Updated: July 10, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014