The Relative Bioavailability and Dose Linearity of Budesonide in Healthy Adult Japanese and Non-Asian Subjects

JRCT ID: jRCT2071240012

Registered date:16/05/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: primary immunoglobulin A nephropathy (IgAN)
• Date of first enrollment: 14/05/2024
• Target sample size: 64
• Study type: Interventional
• Intervention(s): Subjects will be housed the day prior dosing and until at least 36 hours after dosing. There will be 2 periods and at each period, a single, oral 8 mg (2 * 4 mg) or 16 mg (4 * 4 mg) dose of study medication under fasting conditions will take place. There will be at least 7 days but no more than 10 days between dosing times for the treatment periods.

Outcome(s)

• Primary Outcome: The relative bioavailability of VR-205 (budesonide) delayed release capsules 4 mg in Japanese and non-Asian will be determined by a comparison of various pharmacokinetic parameters derived from the plasma concentration-time curves (e.g., AUCL, AUCINF, and CPEAK) of budesonide.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 65age old
• Gender: Both

Include criteria

a. Japanese: Subjects born from Japanese parents and grandparents. If not living in Japan, must be less than 10 years from primary residence in Japan with no significant lifestyle changes, including diet or eating habits, since leaving Japan.
b. Non-Asian: Subjects with parents and grandparents of non-Asian ancestry (e.g., born in the US/Australia/Canada/New Zealand/western or eastern Europe). No more than 6 individuals of Hispanic origin are permitted to participate. If living in Japan, must be less than 10 years from primary residence in their country of origin with no significant lifestyle changes, including diet or eating habits, since moving to Japan.

Exclude criteria

Individuals of African/black, Asian, or pacific islander heritage are not eligible to be part of the non-Asian group.
Social Habits:
a. Use of any tobacco/nicotine-containing product within 6 months of the start of the study.
b. Ingestion of any alcoholic beverage within the 48 hours prior to the initial administration of study medication.
c. Ingestion of any caffeine- or xanthine-containing food or beverage within the 24 hours prior to the initial administration of study medication.
d. Ingestion of any vitamins or herbal products within 7 days prior to the initial administration of the study medication.
e. Any recent, significant change in dietary or exercise habits.
f. History of drug and/or alcohol abuse within one year of start of study.

Related Information

• Primary Sponsor: Kamimoto Masato