Pharmacokinetics of Talsaclidine After Administration to Healthy Subjects

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: [14C]talsaclidine, iv; Drug: [14C]talsaclidine, oral

Study type: Interventional

Funder types: Industry

Identifiers

NCT02264054

506.109

Details and patient eligibility

About

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

Enrollment: 6 patients

Sex: Male

Ages: 50 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

6 participants in 2 patient groups

[14C]talsaclidine, oral

Experimental group

Description:

single dose of 20 mg oral solution

Treatment:

Drug: [14C]talsaclidine, oral

[14C]talsaclidine, iv

Active Comparator group

Description:

single dose of 20 mg intravenous (iv) infusion

Treatment:

Drug: [14C]talsaclidine, iv