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Completed

NCT Number: NCT02264080

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

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.

Completed

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Key information

Conditions

Healthy

Age range

20 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

  • 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

Exclusion criteria

  • 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

Treatment and study plan

WAL2014

Drug

Other names: Talsaclidine

Placebo

Drug

Primary outcomes

  1. Maximum concentration of the analyte in plasma (Cmax)

    Time frame: up to day 14

  2. Time to reach maximum plasma concentration (tmax)

    Time frame: up to day 14

  3. Area under the plasma concentration-time curve (AUC)

    Time frame: up to day 14

  4. Urinary excretion rate

    Time frame: up to day 14

  5. Minimum plasma concentration (Cmin)

    Time frame: up to day 14

  6. Mean residence time (MRT)

    Time frame: up to day 14

  7. Terminal half-life (t1/2)

    Time frame: up to day 14

  8. Distribution volume

    Time frame: up to day 14

  9. Total clearance

    Time frame: up to day 14

  10. Number of subjects with adverse events

    Time frame: up to 22 days

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
1999
Primary completion
1999
First posted
Oct 15, 2014
Registry last updated
Oct 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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