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OpenTrials
Completed

NCT Number: NCT02264054

Pharmacokinetics of Talsaclidine After Administration to Healthy Subjects

Study to investigate metabolism, pharmacokinetic, safety and tolerability of talsaclidine.

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Key information

Conditions

Age range

50 year–65 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
  • Age range from 50 to 65 years
  • Participants should be within 20% of their normal weight (Broca-Index)
  • Written informed consent in accordance with Good Clinical Practice and local legislation

Exclusion criteria

  • Results of the medical examination or laboratory tests (especially those which indicate liver malfunction) are judged by the clinical investigator to differ significantly from normal clinical values
  • Known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Disease of the central nervous system (such as epilepsy) or with psychiatric disorders
  • Known 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 drugs with a long half-life (≥ 24 hours) within one month before enrolment in the study
  • Intake of any other drugs which might influence the results of the trial during the week previous the start of the study
  • Participation in another study with an investigational drug within the last 2 months preceding this study
  • Unability to refrain from smoking on study days
  • Volunteers who smoke more than 10 cigarettes (or 3 cigars or pipes) per day
  • Volunteers who drink more than 40 g of alcohol per day
  • Volunteers who are dependent on drugs
  • Blood donation ((≥ 100 ml) within the last 4 weeks
  • Excessive physical activities (e.g. competitive sports) within the last week before the study

Treatment and study plan

[14C]talsaclidine, oral

Drug

[14C]talsaclidine, iv

Drug

Primary outcomes

  1. [C14]-radioactivity concentration in blood

    Time frame: up to 96 hours after drug administration

  2. [C14]-radioactivity concentration in plasma

    Time frame: up to 96 hours after drug administration

  3. [C14]-radioactivity concentration in urine

    Time frame: up to 96 hours after drug administration

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

    Time frame: up to 96 hours after drug administration

  5. Terminal half-life (t1/2)

    Time frame: up to 96 hours after drug administration

  6. Maximum concentration of the analyte in plasma (Cmax)

    Time frame: up to 96 hours after drug administration

  7. Time to reach maximum plasma concentration (tmax)

    Time frame: up to 96 hours after drug administration

  8. Absolute bioavailability based on AUC

    Time frame: up to 96 hours after drug administration

  9. Drug absorption (fa) based on radioactivity

    Time frame: up to 96 hours after drug administration

Secondary outcomes

  1. Urinary excretion (Ae)

    Time frame: up to 96 hours after drug administration

  2. Mean residence time (MRT)

    Time frame: up to 96 hours after drug administration

  3. Apparent clearance (CL)

    Time frame: up to 96 hours after drug administration

  4. Apparent volume of distribution (Vz/f))

    Time frame: up to 96 hours after drug administration

  5. Plasma protein binding of the [14C] radioactivity

    Time frame: up to 96 hours after drug administration

  6. Number of subjects with adverse events

    Time frame: up to 8 days after last drug administration

  7. Number of subjects with clinically significant findings in vital signs

    Time frame: up to 8 days after last drug administration

    blood pressure, pulse rate

  8. Number of subjects with clinically significant findings in electrocardiogram

    Time frame: up to 8 days after last drug administration

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

    Time frame: up to 8 days after last drug administration

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Investigation of Metabolism and Pharmacokinetics of Talsaclidine After Administration of Single Oral and Single Intravenous Dose of 20 mg of [14C]-Labelled Talsaclidine to 6 Healthy Subjects

Important dates

Study start
1999
Primary completion
1999
First posted
Oct 15, 2014
Registry last updated
Oct 15, 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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