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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: Talsaclidine

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: Talsaclidine; single rising doses	Drug: Talsaclidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean residence time (MRT)	up to 24 hours after drug administration
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
Urinary excretion rate	up to 24 hours after drug administration
Number of subjects with adverse events	up to 8 days after administration

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: July 1, 1998
• Primary Completion (Actual): November 1, 1998

Study Registration Dates

• First Submitted: October 13, 2014
• First Submitted That Met QC Criteria: October 13, 2014
• First Posted (Estimate): October 15, 2014

Study Record Updates

• Last Update Posted (Estimate): October 15, 2014
• Last Update Submitted That Met QC Criteria: October 13, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 506.111