Pharmacokinetics and Safety of WAL2014 (Talsaclidine) in Healthy Male Volunteers

Study Overview
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Brief Summary
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To assess the pharmacokinetics and safety of WAL2014 capsules administered orally as a single dose to healthy adult male volunteers in double blind manner.

Official Title
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Phase I Clinical Study of WAL2014 (Talsaclidine) Capsule: A Single Oral Dose Study

Conditions
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Healthy

Intervention / Treatment
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* Drug: Talsaclidine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects for the study are healthy male adult volunteers who meet all the inclusion criteria listed below and do not fall into the exclusion criteria. Age: 20-30 years old Body weight: 50-80 kg Obesity index: within +/-20% of the standard body weight Those who have received screening examinations listed in protocol within one month prior to the start of the clinical study and have been judged as eligible by the investigator. Results of the simple test for gastric acidity are not used as the basis of the judgment. Those who belong to volunteer members' association which has an office in Clinical Pharmacology Center, Ohsaki Clinic Exclusion Criteria: Those who have a history of allergic reaction or hypersensitivity to drugs Those who have received any kind of drug(s) within one month prior to the administration of the investigational product Those who have ingested alcoholic drink within two days before the administration of the investigational product Those who have been admitted to a hospital, undergone surgery or donated blood within 3 months before the administration of the investigational product Those who have participated in a phase I clinical study of a drug which contains a new active ingredient or a similar study within 4 months before the administration of the investigational product Those who have a history of liver or renal disease Those who are judged as ineligible for the clinical study by the investigator.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Talsaclidine<br>single rising doses | Drug: Talsaclidine<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum concentration of the analyte in plasma (Cmax) |  | up to 24 hours after drug administration | 
| Time to reach maximum plasma concentration (tmax) |  | up to 24 hours after drug administration | 
| Area under the plasma concentration-time curve (AUC) |  | up to 24 hours after drug administration | 
| Distribution volume |  | up to 24 hours after drug administration | 
| Total clearance |  | up to 24 hours after drug administration | 
| Mean residence time (MRT) |  | up to 24 hours after drug administration | 
| Urinary excretion rate |  | up to 24 hours after drug administration | 
| Number of subjects with adverse events |  | up to 8 days after administration |