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

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ClinicalTrials.gov Identifier: NCT01541488
Recruitment Status : Completed
First Posted : March 1, 2012
Last Update Posted : October 31, 2013
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Healthy Drug: BI 1021958 Drug: Placebo to BI 1021958 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
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)
Study Start Date : February 2012
Actual Primary Completion Date : May 2012

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Number of participants with clinically relevant findings in physical examination [ Time Frame: up to 14 days postdose ]
  2. Number of participants with clinically relevant findings in vital signs [ Time Frame: up to 14 days postdose ]
  3. Number of participants with clinically significant abnormalities in electrocardiogram (ECG) results [ Time Frame: up to 14 days postdose ]
  4. Number of participants with significant changes from baseline laboratory measurements [ Time Frame: up to 14 days postdose ]
  5. Number of participants with adverse events [ Time Frame: up to 14 days postdose ]
  6. Assessment of tolerability by investigator [ Time Frame: up to 14 days postdose ]

Secondary Outcome Measures :
  1. Cmax (maximum measured concentration of BI 1021958 in plasma) [ Time Frame: up to 72h postdose ]
  2. 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 ]
  3. 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 ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

1. Healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01541488


Locations
Germany
1310.1.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01541488     History of Changes
Other Study ID Numbers: 1310.1
2011-003483-70 ( EudraCT Number: EudraCT )
First Posted: March 1, 2012    Key Record Dates
Last Update Posted: October 31, 2013
Last Verified: October 2013