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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: WAL2014

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• 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 [standard body weight = (height - 100) x 0.9]
4. 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.
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 week 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 participated in Phase I single dose study of the investigational product
7. Those who have a history of liver or renal disease
8. 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: WAL2014	Drug: WAL2014; Other Names: Talsaclidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: March 1, 1999
• Primary Completion (Actual): March 1, 1999

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: 506.112