Pharmacokinetics of Talsaclidine After Administration to Healthy Subjects

NCT02264054 | Completed Phase 1

• 1 other identifier: 506.109
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (9)

• [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 Outcomes (9)

• 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

Study Arms (2)

[14C]talsaclidine, oral

EXPERIMENTAL

single dose of 20 mg oral solution

Drug: [14C]talsaclidine, oral

[14C]talsaclidine, iv

ACTIVE COMPARATOR

single dose of 20 mg intravenous (iv) infusion

Drug: [14C]talsaclidine, iv

Interventions

[14C]talsaclidine, oral DRUG

[14C]talsaclidine, oral

[14C]talsaclidine, iv DRUG

[14C]talsaclidine, iv

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2014
• First Posted: October 15, 2014
• Study Start: February 1, 1999
• Primary Completion: March 1, 1999
• Last Updated: October 15, 2014

Record last verified: 2014-10