Safety, Tolerability, Pharmacokinetics and Early Pharmacodynamics of Single Rising Oral Doses of BI 1021958 Tablets in Healthy Male Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01541488
First received: February 22, 2012
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

Safety, tolerability, pharmacokinetics and early pharmacodynamics of single rising oral doses of BI 1021958 tablets in healthy male volunteers (first-in-human trial)


Condition Intervention Phase
Healthy
Drug: BI 1021958
Drug: Placebo to BI 1021958
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses (1 mg as Drinking Solution, and 5, 20, 60, 150, 300, 500 mg as Tablets) of BI 1021958 in Healthy Male Volunteers (Placebo-controlled, Randomised and Single Blind Within Dose Groups), Including Investigation of the Effect of Food on the Bioavailability of BI 1021958 (Open-label, Randomised, Two-way Cross-over)

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Number of participants with clinically relevant findings in physical examination [ Time Frame: up to 14 days postdose ] [ Designated as safety issue: Yes ]
  • Number of participants with clinically relevant findings in vital signs [ Time Frame: up to 14 days postdose ] [ Designated as safety issue: Yes ]
  • Number of participants with clinically significant abnormalities in electrocardiogram (ECG) results [ Time Frame: up to 14 days postdose ] [ Designated as safety issue: Yes ]
  • Number of participants with significant changes from baseline laboratory measurements [ Time Frame: up to 14 days postdose ] [ Designated as safety issue: Yes ]
  • Number of participants with adverse events [ Time Frame: up to 14 days postdose ] [ Designated as safety issue: Yes ]
  • Assessment of tolerability by investigator [ Time Frame: up to 14 days postdose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cmax (maximum measured concentration of BI 1021958 in plasma) [ Time Frame: up to 72h postdose ] [ Designated as safety issue: No ]
  • area under the concentration-time curve of BI 1021958 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) [ Time Frame: up to 72h postdose ] [ Designated as safety issue: No ]
  • AUC0-tz (area under the concentration-time curve of BI 1021958 in plasma over the time interval from 0 up to the last quantifiable data point) [ Time Frame: up to 72h postdose ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: February 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 1021958
Single rising dose (SRD) part
Drug: BI 1021958
drinking solution / tablet
Experimental: BI 1021958 (Food effect)
Food effect part (FE)
Drug: BI 1021958
tablet
Placebo Comparator: Placebo to BI 1021958
Matching placebo as drinking solution and tablets
Drug: Placebo to BI 1021958
SRD part: oral administration in fasted state, FE part: oral administration in fasted state and after standard high fat breakfast

  Eligibility

Ages Eligible for Study:   18 Years to 45 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: NCT01541488

Locations
Germany
1310.1.1 Boehringer Ingelheim Investigational Site
Biberach, 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: NCT01541488     History of Changes
Other Study ID Numbers: 1310.1, 2011-003483-70
Study First Received: February 22, 2012
Last Updated: October 30, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on September 16, 2014