Safety, Tolerability and Pharmacodynamics of BIIX 1 XX in Healthy Young Male Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02199873
Recruitment Status : Completed
First Posted : July 25, 2014
Last Update Posted : October 29, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The objective of the present study is to obtain information about the safety and tolerability of BIIX 1 XX, to determine the pharmacologically active dose (range) by performing a methacholine challenge test and to obtain preliminary pharmacokinetic data

Condition or disease Intervention/treatment Phase
Healthy Drug: BIIX 1 XX - single rising dose Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Single Increasing Dose Safety, Tolerability and Pharmacodynamics (Methacholine Challenge) Study After Inhalational Administration of BIIX 1 XX (Single Doses: 5 - 800 mcg) in Healthy Young Male Volunteers (Randomised, Double-blind, Placebo-controlled)
Study Start Date : June 1998
Actual Primary Completion Date : September 1998

Arm Intervention/treatment
Experimental: BIIX 1 XX - single rising dose Drug: BIIX 1 XX - single rising dose
Placebo Comparator: Placebo Drug: Placebo

Primary Outcome Measures :
  1. Number of subjects with adverse events [ Time Frame: up to 3 months ]
  2. Number of subjects with abnormal changes in laboratory parameters [ Time Frame: up to 8 days after last drug administration ]
  3. Change in impedance cardiography [ Time Frame: up to 30 minutes after drug administration ]
  4. Change in cutaneous microcirculation [ Time Frame: up to 30 minutes after drug administration ]

Secondary Outcome Measures :
  1. Change in airway resistance (Raw) after methacholine challenge [ Time Frame: up to 30 minutes after drug administration ]
  2. Change in specific conductance (sGaw) after methacholine challenge [ Time Frame: up to 30 minutes after drug administration ]
  3. AUC (Area under the concentration-time curve of the analyte in plasma) [ Time Frame: up to 168 hours after drug administration ]
  4. Cmax (Maximum measured concentration of the analyte in plasma) [ Time Frame: up to 168 hours after drug administration ]
  5. tmax (Time from dosing to the maximum concentration of the analyte in plasma) [ Time Frame: up to 168 hours after drug administration ]
  6. Ae (Amount of analyte that is eliminated in urine) [ Time Frame: up to 48 hours after drug administration ]
  7. MRT (Mean residence time of the analyte in the body) [ Time Frame: up to 168 hours after drug administration ]
  8. t½ (Terminal half-life of the analyte in plasma) [ Time Frame: up to 168 hours after drug administration ]
  9. CL/F(Apparent clearance of the analyte in plasma following extravascular administration) [ Time Frame: up to 168 hours after drug administration ]

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

Inclusion Criteria:

  • Healthy male volunteers who have Broca-Indices within +-20%
  • Participants in the age range between 21 to 50 years
  • Following the methacholine challenge the airway resistance (Raw) shows an increase of at least 130%
  • In accordance with Good Clinical Practice (GCP) and local legislation each volunteer is supposed to give his written informed consent prior to admission to the study
  • As part of the screening (within 14 days before drug administration), each subject was to receive a complete medical examination (including blood pressure, pulse rate, medical history, documentation of demographics, inclusion/exclusion criteria and concomitant therapy) as well as a 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 one month before enrolment in the study
  • Use of any drugs which might influence the results of the trial 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 (> 60g/day)
  • Drug abuse
  • Blood donation within the last 4 weeks
  • Excessive physical activities within the last week before the study

Additional Information:
Responsible Party: Boehringer Ingelheim Identifier: NCT02199873     History of Changes
Other Study ID Numbers: 1150.1
First Posted: July 25, 2014    Key Record Dates
Last Update Posted: October 29, 2014
Last Verified: October 2014