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Dose Extension Study of BIIX 1 XX in Healthy Young Male Volunteers

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ClinicalTrials.gov Identifier: NCT02198287
Recruitment Status : Completed
First Posted : July 23, 2014
Last Update Posted : July 23, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Safety, tolerability and pharmacokinetic study of BIIX 1 XX in healthy male volunteers.

Condition or disease Intervention/treatment Phase
Healthy Drug: BIIX 1 XX inhalation solution Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Single Increasing Dose Safety and Tolerability Study (Dose Extension) After Inhalational Administration of BIIX 1 XX (Single Doses: 800 - 2000 mcg) in Healthy Young Male Volunteers (Randomised, Double-blind, Placebo-controlled)
Study Start Date : January 1999
Actual Primary Completion Date : April 1999

Arm Intervention/treatment
Experimental: BIIX 1 XX, rising doses Drug: BIIX 1 XX inhalation solution
single doses of 800, 1000, 1200, 1400, 1600, 1800, or 2000 mcg

Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. Number of patients with adverse events [ Time Frame: up to 22 days ]
  2. Number of patients with clinically relevant changes in vital parameters (Blood pressure, Pulse rate) [ Time Frame: up to 8 days after drug administration ]
  3. Number of patients with clinically relevant changes in electrocardiogram (ECG) [ Time Frame: up to 8 days after drug administration ]
  4. Number of patients with clinically relevant changes in impedance cardiography [ Time Frame: pre-dose, 10 and 30 minutes after administration ]
  5. Number of patients with clinically relevant changes in cutaneous microcirculation [ Time Frame: pre-dose, 10 and 30 minutes after administration ]
  6. Number of patients with clinically relevant changes in safety laboratory parameters [ Time Frame: up to 8 days after drug administration ]

Secondary Outcome Measures :
  1. Maximum concentration of the drug in plasma (Cmax) [ Time Frame: up to 168 hours after drug administration ]
  2. Area under the plasma drug concentration-time curve from zero time to the last time point of measurement (AUC0-tz) [ Time Frame: up to 168 hours after drug administration ]
  3. Terminal half-life of the analyte in plasma (t1/2) [ Time Frame: up to 168 hours after drug administration ]
  4. Clearance, divided by f (CL/f) [ 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
Criteria

Inclusion Criteria:

  • Healthy males, based on a complete medical examination
  • Age range from 21 to 50 years
  • Participant must be within +/- 20 % of their normal weight (Broca-Index)
  • Participant must provide written informed consent

Exclusion Criteria:

  • Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) or laboratory tests deviating from normal and of clinical relevance
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Diseases of the central nervous system (such as epilepsy) or 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 at least one month or less than then half-lives of the respective drug before enrolment in the study
  • Use of any drugs which might influence the results of the trial within seven days prior to administration or during the trial
  • Participation in another trial with an investigational drug within two months prior to start of the study
  • Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day)
  • Inability to refrain from smoking on study days
  • Alcohol abuse
  • Drug abuse
  • Blood donation (> 100 ml) within four weeks prior to administration
  • Other disease or abnormality of clinical relevance
  • Excessive physical activities within two weeks prior to administration or during the trial

Additional Information:
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02198287     History of Changes
Other Study ID Numbers: 1150.7
First Posted: July 23, 2014    Key Record Dates
Last Update Posted: July 23, 2014
Last Verified: July 2014