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Safety, Tolerability, Pharmacokinetics of Single Rising Oral Doses of BI 1181181 in Healthy Male Volunteers, Including Investigation of the Effect of Food on the Bioavailability of BI 1181181

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ClinicalTrials.gov Identifier: NCT02044406
Recruitment Status : Completed
First Posted : January 24, 2014
Last Update Posted : October 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
To investigate the safety, tolerability, pharmacokinetics (including dose proportionality assessment), and pharmacodynamics of single rising oral doses of BI 1181181 (Single rising dose (SRD) part) Secondly, to investigate the relative bioavailability of the tablet versus the powder for oral solution (PfOS) and the effect of food on the pharmacokinetics of BI 1181181 (Bioavailability/Food effect (BA/FE) part)

Condition or disease Intervention/treatment Phase
Healthy Drug: BI 1181181 Drug: BI 1181181, R Drug: BI 1181181, T2 Drug: Placebo to BI 1181181 Drug: BI 1181181, T1 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 1181181 in Healthy Male Volunteers in a Partially Randomised, Single-blind, Placebo-controlled Trial, and Investigation of Relative Bioavailability and the Effect of Food on the Pharmacokinetics of BI 1181181(Open-label, Randomised, Three-way Cross-over Design)
Study Start Date : January 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Arm Intervention/treatment
Experimental: 1 BI 1181181 single rising dose part
single rising doses of BI 1181181
Drug: BI 1181181
single dose (low to high dose)

Drug: Placebo to BI 1181181
Placebo to BI 1181181

Experimental: 2 BI 1181181 bioavailability part
bioavailability, food effect part of BI 11881181
Drug: BI 1181181, R
powder for oral solution

Drug: BI 1181181, T2
tablet, fasted

Drug: BI 1181181, T1
tablet, fed




Primary Outcome Measures :
  1. Number (%) of subjects with drug-related adverse events (AEs) [ Time Frame: up to 72 h ]
  2. AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) [ Time Frame: up to 72 h ]
  3. Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 72 h ]

Secondary Outcome Measures :
  1. Aet1-t2 (Amount of analyte that is eliminated in urine from the time point t1 to timepoint t2 after single dose administration) [ Time Frame: up to 72 h ]
  2. Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 72 h ]
  3. tmax (time from dosing to maximum measured concentration of the analyte in plasma) [ Time Frame: up to 72 h ]
  4. 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 h ]
  5. t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: up to 72 h ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Healthy males according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs blood pressure (BP), pulse rate (PR), 12-lead ECG, and clinical laboratory tests
  • Age 18 to 50 years (incl.)
  • Body mass index (BMI) 18.5 to 29.9 kg/m2 (incl.)
  • Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

Exclusion criteria:

  • Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged clinically relevant by the investigator
  • Repeated measurement of systolic blood pressure < 90 mmHg and >= 140 mmHg at screening
  • Repeated measurement of diastolic blood pressure < 55 and >= 90 mmHg at screening
  • Repeated measurement of pulse rate < 50 bpm and > 90 bpm at screening
  • Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
  • Any evidence of a concomitant disease judged clinically relevant by the investigator
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

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): NCT02044406


Locations
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Germany
1344.1.1 Boehringer Ingelheim Investigational Site
Ingelheim, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02044406     History of Changes
Other Study ID Numbers: 1344.1
2013-002868-88 ( EudraCT Number: EudraCT )
First Posted: January 24, 2014    Key Record Dates
Last Update Posted: October 8, 2014
Last Verified: October 2014