Investigation of the Food Effect on the Pharmacokinetics of JT408T

JRCT ID: jRCT2051210024

Registered date:11/05/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Improvement of neurological symptoms of Gaucher's disease
• Date of first enrollment: 10/06/2021
• Target sample size: 16
• Study type: Interventional

Intervention(s)

1) After fasting, administer 400 mg of ambroxol hydrochloride orally in a single dose.
2) After meals, administer 400 mg of ambroxol hydrochloride orally in a single dose.

Outcome(s)

• Primary Outcome: The incidence of adverse events and side effects

Secondary Outcome

Pharmacokinetic
- Serum JT408T concentrations
- Pharmacokinetic parameters

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 35age old
• Gender: Male

Include criteria

1) Personally provided written voluntary informed consent to participate in the study
2) Japanese men aged >= 20 and < 35 years at the time of informed consent
3) BMI >= 18.5 and < 25.0 kg/m2 and Weight >=50.0kg <75.0kg at screening
4) Patients who can agree to the contraception from the start JT408T administration to the time of final observation. And patients who can agree not to donate sperm for the purpose of fertilization, etc.

Exclude criteria

1) Persons who have abnormal findings in medical examinations and various tests, and the investigator has determined that there is a clinical problem.
2)Persons with complications or medical history that are considered inappropriate for participation in this study. (Liver disorder, renal disorder, cardiovascular disease, endocrine system disease, metabolic disease, respiratory system disease, neurological disease, urinary system disease, immune system disease, psychiatric disease, etc.)
3)Persons who have or have a history of allergies to drugs or food, or who are suspected of having any of them
4)Persons who have been diagnosed with malignant tumors (including those who have a history within 5 years before obtaining consent)
5)Persons who have undergone surgical operations that are known to affect the gastrointestinal absorption of drugs.

Related Information

• Primary Sponsor: Yutaka Shunichiro