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

NCT02264080 | Completed Phase 1

• 1 other identifier: 506.112
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (2)

WAL2014

EXPERIMENTAL

Drug: WAL2014

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

WAL2014 DRUG

Also known as: Talsaclidine

WAL2014

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 \[standard body weight = (height - 100) x 0.9\]
• 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
• 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

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: March 1, 1999
• Primary Completion: March 1, 1999
• Last Updated: October 15, 2014

Record last verified: 2014-10