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Completed

NCT Number: NCT02198287

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

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

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Key information

Conditions

Age range

21 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BIIX 1 XX inhalation solution

Drug

single doses of 800, 1000, 1200, 1400, 1600, 1800, or 2000 mcg

Placebo

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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)

Important dates

Study start
1999
Primary completion
1999
First posted
Jul 23, 2014
Registry last updated
Jul 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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