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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Talsaclidine; Drug: Placebo

• Registration Number: NCT02264067
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 1998-07
• Primary Completion: 1998-11
• Status Verified: 2014-10
• Study First Submitted: 2014-10-13
• Study First Submitted QC: 2014-10-13
• Last Update Submitted: 2014-10-13
• Study First Posted: 2014-10-15
• Last Update Posted: 2014-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

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.

1. Age: 20-30 years old
2. Body weight: 50-80 kg
3. Obesity index: within +/-20% of the standard body weight
4. 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.
5. Those who belong to volunteer members' association which has an office in Clinical Pharmacology Center, Ohsaki Clinic

Exclusion Criteria

1. Those who have a history of allergic reaction or hypersensitivity to drugs
2. Those who have received any kind of drug(s) within one month prior to the administration of the investigational product
3. Those who have ingested alcoholic drink within two days before the administration of the investigational product
4. Those who have been admitted to a hospital, undergone surgery or donated blood within 3 months before the administration of the investigational product
5. 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
6. Those who have a history of liver or renal disease
7. Those who are judged as ineligible for the clinical study by the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Talsaclidine	Talsaclidine	single rising doses
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Mean residence time (MRT)	up to 24 hours after drug administration
Urinary excretion rate	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
Maximum concentration of the analyte in plasma (Cmax)	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
Number of subjects with adverse events	up to 8 days after administration