Healthy
Conditions
Brief summary
Study to investigate metabolism, pharmacokinetic, safety and tolerability of talsaclidine.
Interventions
DRUG[14C]talsaclidine, oral
DRUG[14C]talsaclidine, iv
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| [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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with clinically significant findings in laboratory tests | up to 8 days after last drug administration | — |
| 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 | up to 8 days after last drug administration | blood pressure, pulse rate |
| Number of subjects with clinically significant findings in electrocardiogram | up to 8 days after last drug administration | — |
Outcome results
None listed