Randomized Crossover of SVG101(Dispersible Tab. of Everolimus) and Afinitor 5mg in Healthy Adults

Phase 1

Completed

• Conditions: Pharmacokinetics
• Interventions: Drug: SVG101 (T); Drug: Afinitor (R)

• Registration Number: NCT05490095
• Lead Sponsor: SoVarGen Co., Ltd.

Brief Summary

The purpose of this study is to determine the pharmacokinetics and safety of SVG101 (dispersible tab. of everolimus) in healthy volunteers compared to Afinitor tab. after oral administration.

Detailed Description

This is a randomized, open-label, single-dose, two-way cross-over study to investigate the Pharmacokinetic characteristics and safety after oral administration of SVG101 (dispersible tablet of everolimus) 5mg and Afinitor 5mg in 26 healthy volunteers.

Study Timeline

• Study Start: 2021-07-23
• Primary Completion: 2022-01-28
• Study Completion: 2022-02-07
• Status Verified: 2022-08
• Study First Submitted: 2022-08-02
• Study First Submitted QC: 2022-08-03
• Last Update Submitted: 2022-08-03
• Study First Posted: 2022-08-05
• Last Update Posted: 2022-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

1. Healthy adults: 19y - 55y (Male or Female)
2. Male: more than 55kg, Female: more than 50kg body weight
3. Body mass index: more than 18.5kg/m^2 and less than 27.0kg/m^2
4. Menopause or surgical infertility female

Exclusion Criteria

1. Participants have or had a history of the clinically relevant disease or abnormalities in the hepatobiliary system, kidney, nervous system, immune system, respiratory system, urinary system, digestive system, endocrine system, blood/tumor, cardiovascular system, and mental illness.
2. Participants with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
3. Any history of gastrointestinal disease or surgery
4. Participants have hypersensitive to the everolimus or other rapamycin derivatives or other components of the investigational product.
5. Taking any drugs that induce or inhibit metabolizing enzymes such as barbiturate drugs within 30 days prior to first administration
6. Receiving any investigational therapy of others within 180 days prior to first administration. In case of biological products, the restricted period can be extended depend on the half-life receipt product
7. Pregnant or breastfeeding women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group I	Afinitor (R)	13 subjects will receive 1. First Dose: Afinitor 5mg, single dose 2. Wash out period : more than 10 days 3. Second Dose: SVG101 5mg, single dose
Group II	Afinitor (R)	13 subjects will receive 1. First Dose: SVG101 5mg, single dose 2. Wash out period : more than 10 days 3. Second Dose: Afinitor 5mg, single dose
Group II	SVG101 (T)	13 subjects will receive 1. First Dose: SVG101 5mg, single dose 2. Wash out period : more than 10 days 3. Second Dose: Afinitor 5mg, single dose
Group I	SVG101 (T)	13 subjects will receive 1. First Dose: Afinitor 5mg, single dose 2. Wash out period : more than 10 days 3. Second Dose: SVG101 5mg, single dose

Primary Outcome Measures

Name	Time	Method
Vd/F of Everolimus	up to 144 hours
Cmax of Everolimus	up to 144 hours
AUCinf of everolimus	up to 144 hours
Cmin,ss,pred of Everolimus	up to 144 hours
AUClast of Everolimus	up to 144 hours
Clearance of Everolimus	up to 144 hours
t1/2 of Everolimus	up to 144 hours
Tmax of Everolimus	up to 144 hours

Secondary Outcome Measures

Name	Time	Method
Adverse Events (AEs)	up to approximately 45 days

Trial Locations

Locations (1)

Yonsei University Healthcare System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of