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Completed

NCT Number: NCT02222961

Single Increasing Dose Followed by Maintenance Dose Tolerance Study of BIIR 561 CL in Healthy Male Volunteers

The objective of the present study is to obtain information about the safety, tolerability and pharmacokinetics of BIIR 561 after continuous intravenous administration of increasing doses in healthy young volunteers

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Key information

Conditions

Healthy

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 male volunteers
  • Age 21 to 50 years
  • Broca index from -20% to +20%
  • Written informed consent prior to admission to the study

Exclusion criteria

  • Medical examination, laboratory tests or ECG judged by the investigator to differ significantly from normal clinical values
  • Known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Known diseases of the central nervous system (CNS) (such as epilepsy), CNS trauma in their medical history or with psychiatric or neurological disorders
  • Known history of orthostatic hypotension, fainting spells or blackouts
  • Chronic or relevant acute infections
  • 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 ten half-lives of the respective drug before enrolment in the study
  • Intake of any other drug 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)
  • Alcohol use of more than 60 g per day
  • Drug dependency
  • Excessive physical activities (e.g. competitive sports) within the last week before the study
  • Blood donation within the last 4 weeks (>= 100 ml)

Treatment and study plan

BIIR 561 CL

Drug

Placebo

Drug

Primary outcomes

  1. Number of subjects with adverse events

    Time frame: up to 8 days after drug administration

  2. Number of subjects with clinically significant findings in vital functions

    Time frame: up to 8 days after drug administration

    blood pressure, pulse rate, respiratory rate, oral body temperature

  3. Number of subjects with clinically significant findings in ECG

    Time frame: up to 8 days after drug administration

  4. Number of subjects with clinically significant findings in laboratory tests

    Time frame: up to 8 days after drug administration

Secondary outcomes

  1. Maximum concentration in plasma (Cmax)

    Time frame: up to 32 hours after first drug administration

  2. Time to maximum concentration in plasma (tmax)

    Time frame: up to 32 hours after first drug administration

  3. Terminal half-life (t1/2)

    Time frame: up to 32 hours after first drug administration

  4. Area under the plasma concentration-time curve from zero to the last time points with a quantifiable plasma concentration (AUC0-tf)

    Time frame: up to 32 hours after first drug administration

  5. Area under the plasma concentration-time curve extrapolated to infinity (AUC0-inf)

    Time frame: up to 32 hours after first drug administration

  6. Total Mean residence time (MRTtot)

    Time frame: up to 32 hours after first drug administration

  7. Total plasma clearance (CLtot)

    Time frame: up to 32 hours after first drug administration

  8. Volume of distribution (Vz)

    Time frame: up to 32 hours after first drug administration

  9. Volume of distribution at steady state (Vss)

    Time frame: up to 32 hours after first drug administration

  10. Amount excreted into urine (Ae)

    Time frame: up to 32 hours after first drug administration

  11. Mean residence time of disposition (MRTdisp)

    Time frame: up to 32 hours after first drug administration

  12. Renal clearance (CLR)

    Time frame: up to 32 hours after first drug administration

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Single-blind, Placebo-controlled Single Increasing Dose Tolerance Study in Healthy Male Volunteers After Intravenous Administration of BIIR 561 CL as Loading Dose (Dosage: 37.5 mg/h - 150 mg/h, Infusion Time 1 Hour) Followed by Maintenance Dose (Dosage: 20 mg/h - 40 to 125 mg/h), Infusion Time 5 Hours

Important dates

Study start
1999
Primary completion
2000
First posted
Aug 22, 2014
Registry last updated
Aug 22, 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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