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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: WAL2014; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02264080

506.112

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: Male

Ages: 20 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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12 participants in 2 patient groups, including a placebo group

WAL2014

Experimental group

Treatment:

Drug: WAL2014

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo