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Multiple Rising Dose of BI 1181181 Given Orally in Young Healthy Male and Elderly Healthy Male/Female Volunteers

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ClinicalTrials.gov Identifier: NCT02254161
Recruitment Status : Terminated
First Posted : October 1, 2014
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The primary objective of the current study is to investigate the safety and tolerability of BI 1181181 in healthy young male and elderly male and female volunteers following oral administration of repeated rising doses of BI 1181181, given once daily over 10 days. Secondary objectives are the exploration of the pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1181181.

Condition or disease Intervention/treatment Phase
Healthy Drug: Matching placebo Drug: BI 1181181 healthy elderly Drug: BI 1181181 Healthy young Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Doses of BI 1181181 Given Orally q.d. for 10 Days in Young Healthy Male and Elderly Healthy Male/Female Volunteers (Randomized, Double-blind, Placebo Controlled Within Dose Groups Phase I Study)
Study Start Date : November 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Arm Intervention/treatment
Experimental: BI 1181181 healthy young
Medium doses as tablets q.d. for 10 days
Drug: BI 1181181 Healthy young
Tablet

Experimental: BI 1181181 healthy elderly
Medium doses as tablets q.d. for 10 days
Drug: BI 1181181 healthy elderly
Tablet

Placebo Comparator: Matching placebo in healthy young
Matching placebo for 10 days
Drug: Matching placebo
Tablet

Placebo Comparator: Matching placebo in healthy elderly
Matching placebo for 10 days
Drug: Matching placebo
Tablet




Primary Outcome Measures :
  1. frequency [N (%)] of subjects with drug-related adverse events [ Time Frame: days 1 to 24 ]

Secondary Outcome Measures :
  1. Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) after administration of the last dose [ Time Frame: 0 to 336 hours ]
  2. Cmax,ss (maximum measured concentration of the analyte in CSF (if feasible) at steady state over a uniform dosing interval t) after administration of the last dose [ Time Frame: 0 to 336 hours ]
  3. AUCt,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t after administration of the first dose) [ Time Frame: 0 to 336 hours ]
  4. Cmax (maximum measured concentration of the analyte in plasma) after administration of the first dose [ Time Frame: 0 to 336 hours ]
  5. AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) after the administration of the last dose [ Time Frame: 0 to 336 hours ]
  6. AUCt,ss (area under the concentration-time curve of the analyte in CSF (if feasible) at steady state over a uniform dosing interval t after the administration of the last dose [ Time Frame: 0 to 336 hours ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. Healthy male or female subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests.
  2. Age of 18 to 50 years (incl.) for young healthy volunteers or of 65 to 80 years (incl.) for elderly healthy volunteers.
  3. BMI of 18.5 to 29.9 kg/m2 (incl.)
  4. Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.

Exclusion criteria:

  1. Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator
  2. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
  3. Any evidence of a concomitant disease judged as clinically relevant by the investigator
  4. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  5. Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication (except appendectomy)
  6. Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric 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): NCT02254161


Locations
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Germany
1344.2.1 Boehringer Ingelheim Investigational Site
Berlin, 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: NCT02254161     History of Changes
Other Study ID Numbers: 1344.2
2014-002482-30 ( EudraCT Number: EudraCT )
First Posted: October 1, 2014    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018