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Completed

NCT Number: NCT02269215

Single Increasing Doses of BIII 890 CL in Healthy Young Male Volunteers and in Healthy Elderly Male and Female Volunteers

Safety, tolerability and pharmacokinetics of BIII 890

Completed

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Key information

Conditions

Healthy

Age range

21 year and older

Sex eligibility

All sexes

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

  • Participants in the study should be healthy males, range from 21 to 50 years of age and be within +- 20% of their normal weight (Broca-Index) and healthy elderly males and females, > 60 years of age and be within +-25 % of their normal weight (Broca-Index)
  • In accordance with good clinical practice (GCP) and the local legislation all volunteers will have given their written informed consent prior to admission to the study

Exclusion criteria

  • Volunteers were excluded from the study if the results of the medical examination, laboratory tests or ECG recordings are judged by the 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), central nervous system (CNS) trauma in their medical history or with psychiatric disorders or neurological disorders
  • Volunteers with known history of relevant orthostatic hypotension, fainting spells or blackouts
  • Volunteers with chronic or relevant acute infections
  • Volunteers with history of allergy/hypersensitivity (including drug allergy) which was deemed relevant to the trial as, judged by the investigator
  • Volunteers who had taken 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
  • Volunteers who received any other drugs which could influence the results of the trial during the week prior to the start of the study
  • Volunteers who participated in another study with an investigational drug within the last two months preceding this study
  • Volunteers who smoke (> 10 cigarettes or 3 cigars or 3 pipes/day)
  • Volunteers who were not able to refrain from smoking on study days
  • Volunteers who drunk more than 60 g of alcohol per day
  • Volunteers who were dependent on drugs
  • Volunteers who participated in excessive physical activities (e.g. competitive sports) during the last week before the study
  • Volunteers who donated blood within the last 4 weeks (≥ 100 mL)

Treatment and study plan

BIII 890 CL

Drug

Placebo

Drug

Primary outcomes

  1. Number of patients with clinically relevant changes in vital signs

    Time frame: Pre-dose, up to 8 days after drug administration

    blood pressure, pulse rate, respiratory rate, body temperature

  2. Number of subjects with clinically relevant changes in 12-lead ECG

    Time frame: Pre-dose, up to 8 days after drug administration

  3. Number of subjects with clinically relevant changes in laboratory parameters

    Time frame: Pre-dose, up to 8 days after drug administration

    including coagulation parameters

  4. Number of subjects with adverse events

    Time frame: Up to 8 days after drug administration

Secondary outcomes

  1. Maximum measured concentration of the analyte in plasma (Cmax)

    Time frame: up to 32 hours after start of drug administration

  2. Time from dosing to the maximum concentration of the analyte in plasma over a uniform dosing interval λz (tmax)

    Time frame: up to 32 hours after start of drug administration

  3. Apparent terminal half-life of the analyte in plasma (t1/2)

    Time frame: up to 32 hours after start of drug administration

  4. Area under the concentration-time curve of the analyte in plasma (AUC)

    Time frame: up to 32 hours after start of drug administration

  5. Mean residence time (MRT)

    Time frame: up to 32 hours after start of drug administration

  6. Plasma clearance (CL)

    Time frame: up to 32 hours after start of drug administration

  7. Volume of distribution (V)

    Time frame: up to 32 hours after start of drug administration

  8. Amount of parent drug excreted into urine (Ae)

    Time frame: up to 32 hours after start of drug administration

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Single Blind, Placebo-controlled, Parallel-group, Single Increasing Dose Tolerance Study in Healthy Young Male Volunteers After Intravenous Administration of BIII 890 CL as Loading Dose (Dosage: 12.5, 25, 50 mg/h, Infusion Time 1 hr; 50 mg/h, Infusion Time 2 Hrs) Followed by Maintenance Dose (Dosage: 6.25, 12.5, 25 mg/h, Infusion Time 5 Hrs; 30 mg/h, Infusion Time 4 Hrs) and in Healthy Elderly Male and Female Volunteers After Intravenous Administration of BIII 890 CL as Loading Dose (Dosage: 50 mg/h, Infusion Time 1 hr) Followed by Maintenance Dose (Dosage: 25 mg/h, Infusion Time 5 Hrs)

Important dates

Study start
2000
Primary completion
2000
First posted
Oct 21, 2014
Registry last updated
Oct 21, 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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