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

NCT02264067 | Completed Phase 1

• 1 other identifier: 506.111
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

Talsaclidine

EXPERIMENTAL

single rising doses

Drug: Talsaclidine

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Talsaclidine DRUG

Talsaclidine

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

talsaclidine fumarate

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2014
• First Posted: October 15, 2014
• Study Start: July 1, 1998
• Primary Completion: November 1, 1998
• Last Updated: October 15, 2014

Record last verified: 2014-10