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Safety, Tolerability and Pharmacokinetics of Increasing Repeated Doses of BIIF 1149 BS in Healthy Male Volunteers

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ClinicalTrials.gov Identifier: NCT02203487
Recruitment Status : Completed
First Posted : July 30, 2014
Last Update Posted : July 30, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The objective of the present study was to obtain information about the safety and tolerability of BIIF 1149 BS after repeated dosing and to obtain preliminary pharmacokinetics data (steady state and accumulation factor)

Condition or disease Intervention/treatment Phase
Healthy Drug: BIIF 1149 BS - single rising dose Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-blind (Within Dose Groups), Randomised, Placebo-controlled, Parallel-group Study to Investigate the Safety, Tolerability and Preliminary Pharmacokinetics of Increasing Repeated Oral Doses (Nine Days Treatment of 5 mg and 10 mg and Eighteen Days Treatment of 25 mg and 40 mg) of BIIF 1149 BS in Healthy Male Volunteers
Study Start Date : November 1999
Actual Primary Completion Date : June 2000

Arm Intervention/treatment
Experimental: BIIF 1149 BS - single rising dose Drug: BIIF 1149 BS - single rising dose
Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. Number of subjects with adverse events [ Time Frame: up to 55 days ]
  2. Number of subjects with abnormal changes in laboratory parameters [ Time Frame: up to 8 days after last blood sample ]
  3. Number of subjects with clinically significant changes in vital signs (blood pressure, pulse rate) [ Time Frame: up to 8 days after last blood sample ]

Secondary Outcome Measures :
  1. Number of subjects with clinically significant changes in 12-lead Electrocardiogram (ECG) [ Time Frame: up to 8 days after last blood sample ]
  2. Cmax (Maximum concentration of the analyte in plasma) [ Time Frame: up to 360 hours after last drug administration ]
  3. Tmax (Time to maximum observed concentration of the analyte in plasma) [ Time Frame: up to 360 hours after last drug administration ]
  4. AUC (Area under the concentration-time curve of the analyte in plasma) [ Time Frame: up to 360 hours after last drug administration ]
  5. Ae (Urinary excretion of parent drug) [ Time Frame: up to 120 hours after last drug administration ]
  6. Cmin,ss (Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) [ Time Frame: after 24 hours of drug administration on day 9 ]
  7. MRT (Mean residence time of the analyte in the body) [ Time Frame: up to 360 hours after last drug administration ]
  8. t½ (Terminal half-life of the analyte in plasma) [ Time Frame: up to 360 hours after last drug administration ]
  9. Percent peak-trough fluctuation [ Time Frame: up to 360 hours after last drug administration ]
  10. RA (AUC) Accumulation factor based on AUC-data [ Time Frame: up to 360 hours after last drug administration ]
  11. RA (Ae) Accumulation factor based on Ae-data [ Time Frame: up to 120 hours after last drug administration ]
  12. RA (Cmax) Accumulation factor based on Cmax -data [ Time Frame: up to 360 hours after drug administration on day 9 ]
  13. Cav (Average plasma concentration in a steady state interval) [ Time Frame: 24 hours after drug administration of day 9 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants should be healthy males
  • Age range from 21 to 50 years
  • Within +- 20% of their normal weight (Broca-Index)
  • In accordance with Good Clinical Practice (GCP) and local legislation each volunteers are supposed to give their written informed consent prior to admission to the study
  • Each subject will have his medical history taken and will receive a complete medical examination (incl. demographics, medical history, check of inclusion/exclusion criteria, physical examination, vital signs, 12-lead Electrocardiogram (ECG)
  • Haematopoietic, hepatic and renal function test will be carried out in the laboratory
  • The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations. The above mentioned examinations will be performed within 14 days before the first administration of the test substance

Exclusion Criteria:

  • Volunteers will be excluded from the study if the results of the medical examination or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values
  • Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Volunteers with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
  • History of orthostatic hypotension, fainting spells or blackouts
  • Chronic or relevant acute infections
  • History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
  • Intake of a drug with a long half-life (>= 24 hours) within ten half-lives of the respective drug before enrolment in the study
  • Use of any other drugs which might influence the results of the trial during the week previous to the start of the study
  • Participation in another study with an investigational drug within the last two months preceding this study
  • Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day)
  • Inability to refrain from smoking on study days
  • Alcohol abuse (> 40g/day)
  • Drug abuse
  • Blood donation (>= 100 ml) within the last 4 weeks
  • Excessive physical activities (e.g. competitive sports) within the last week before the study
Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02203487    
Other Study ID Numbers: 1157.3
First Posted: July 30, 2014    Key Record Dates
Last Update Posted: July 30, 2014
Last Verified: July 2014