Pharmacokinetics of Talsaclidine After Administration to Healthy Subjects

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

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: [14C]talsaclidine, oral
* Drug: [14C]talsaclidine, iv


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [14C]talsaclidine, oral<br>single dose of 20 mg oral solution | Drug: [14C]talsaclidine, oral<br> <br> |
| Active Comparator: [14C]talsaclidine, iv<br>single dose of 20 mg intravenous (iv) infusion | Drug: [14C]talsaclidine, iv<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| [C14]-radioactivity concentration in blood |  | up to 96 hours after drug administration | 
| [C14]-radioactivity concentration in plasma |  | up to 96 hours after drug administration | 
| [C14]-radioactivity concentration in urine |  | up to 96 hours after drug administration | 
| Area under the plasma concentration-time curve (AUC) |  | up to 96 hours after drug administration | 
| Terminal half-life (t1/2) |  | up to 96 hours after drug administration | 
| Maximum concentration of the analyte in plasma (Cmax) |  | up to 96 hours after drug administration | 
| Time to reach maximum plasma concentration (tmax) |  | up to 96 hours after drug administration | 
| Absolute bioavailability based on AUC |  | up to 96 hours after drug administration | 
| Drug absorption (fa) based on radioactivity |  | up to 96 hours after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary excretion (Ae) |  | up to 96 hours after drug administration | 
| Mean residence time (MRT) |  | up to 96 hours after drug administration | 
| Apparent clearance (CL) |  | up to 96 hours after drug administration | 
| Apparent volume of distribution (Vz/f)) |  | up to 96 hours after drug administration | 
| Plasma protein binding of the [14C] radioactivity |  | up to 96 hours after drug administration | 
| Number of subjects with adverse events |  | up to 8 days after last drug administration | 
| Number of subjects with clinically significant findings in vital signs | blood pressure, pulse rate | up to 8 days after last drug administration | 
| Number of subjects with clinically significant findings in electrocardiogram |  | up to 8 days after last drug administration | 
| Number of subjects with clinically significant findings in laboratory tests |  | up to 8 days after last drug administration |