Pharmacokinetics of Talsaclidine After Administration to Healthy Subjects

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: [14C]talsaclidine, oral; Drug: [14C]talsaclidine, iv

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
Number of subjects with adverse events		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
Number of subjects with clinically significant findings in vital signs	blood pressure, pulse rate	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 clinically significant findings in electrocardiogram		up to 8 days after last drug administration

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: February 1, 1999
• Primary Completion (Actual): March 1, 1999

Study Registration Dates

• First Submitted: October 13, 2014
• First Submitted That Met QC Criteria: October 13, 2014
• First Posted (Estimate): October 15, 2014

Study Record Updates

• Last Update Posted (Estimate): October 15, 2014
• Last Update Submitted That Met QC Criteria: October 13, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 506.109