Pharmacokinetics and Safety of WAL2014 (Talsaclidine) Administered Orally to Healthy Adult Male Volunteers

Study Overview
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Brief Summary
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Study to assess the pharmacokinetics and safety of WAL2014 capsules administered orally as a multiple 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 Multiple Oral Dose Study

Conditions
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Healthy

Intervention / Treatment
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* Drug: WAL2014
* 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 [standard body weight = (height - 100) x 0.9] Those who have received screening examinations listed in Table 1 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 week 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 participated in Phase I single dose study 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: WAL2014<br> | Drug: WAL2014<br> <br> * Other names: Talsaclidine;|
| 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 day 14 | 
| Time to reach maximum plasma concentration (tmax) |  | up to day 14 | 
| Area under the plasma concentration-time curve (AUC) |  | up to day 14 | 
| Urinary excretion rate |  | up to day 14 | 
| Minimum plasma concentration (Cmin) |  | up to day 14 | 
| Mean residence time (MRT) |  | up to day 14 | 
| Terminal half-life (t1/2) |  | up to day 14 | 
| Distribution volume |  | up to day 14 | 
| Total clearance |  | up to day 14 | 
| Number of subjects with adverse events |  | up to 22 days |