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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Notify MeKey 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, iv
DrugPrimary outcomes
-
[C14]-radioactivity concentration in blood
Time frame: up to 96 hours after drug administration
-
[C14]-radioactivity concentration in plasma
Time frame: up to 96 hours after drug administration
-
[C14]-radioactivity concentration in urine
Time frame: up to 96 hours after drug administration
-
Area under the plasma concentration-time curve (AUC)
Time frame: up to 96 hours after drug administration
-
Terminal half-life (t1/2)
Time frame: up to 96 hours after drug administration
-
Maximum concentration of the analyte in plasma (Cmax)
Time frame: up to 96 hours after drug administration
-
Time to reach maximum plasma concentration (tmax)
Time frame: up to 96 hours after drug administration
-
Absolute bioavailability based on AUC
Time frame: up to 96 hours after drug administration
-
Drug absorption (fa) based on radioactivity
Time frame: up to 96 hours after drug administration
Secondary outcomes
-
Urinary excretion (Ae)
Time frame: up to 96 hours after drug administration
-
Mean residence time (MRT)
Time frame: up to 96 hours after drug administration
-
Apparent clearance (CL)
Time frame: up to 96 hours after drug administration
-
Apparent volume of distribution (Vz/f))
Time frame: up to 96 hours after drug administration
-
Plasma protein binding of the [14C] radioactivity
Time frame: up to 96 hours after drug administration
-
Number of subjects with adverse events
Time frame: up to 8 days after last drug administration
-
Number of subjects with clinically significant findings in vital signs
Time frame: up to 8 days after last drug administration
blood pressure, pulse rate
-
Number of subjects with clinically significant findings in electrocardiogram
Time frame: up to 8 days after last drug administration
-
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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