Clinical trial NCT02264080: Pharmacokinetics and Safety of WAL2014 (Talsaclidine) Administered Orally to Healthy Adult Male Volunteers
Official title: Phase I Clinical Study of WAL2014 (Talsaclidine) Capsule: A Multiple Oral Dose Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-15
Enrollment: 12
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum concentration of the analyte in plasma (Cmax)
timeFrame: up to day 14
measure: Time to reach maximum plasma concentration (tmax)
timeFrame: up to day 14
measure: Area under the plasma concentration-time curve (AUC)
timeFrame: up to day 14
measure: Urinary excretion rate
timeFrame: up to day 14
measure: Minimum plasma concentration (Cmin)
timeFrame: up to day 14
measure: Mean residence time (MRT)
timeFrame: up to day 14
measure: Terminal half-life (t1/2)
timeFrame: up to day 14
measure: Distribution volume
timeFrame: up to day 14
measure: Total clearance
timeFrame: up to day 14
measure: Number of subjects with adverse events
timeFrame: up to 22 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: