Clinical trial NCT02264054: Pharmacokinetics of Talsaclidine After Administration to Healthy Subjects
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-15
Enrollment: 6
Sex: MALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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

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