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

A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetic and Safety After Oral Administration of SVG101(Dispersible Tablet of Everolimus) 5mg and Afinitor 5mg in Healthy Adults

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.

Study Overview

• Status: Completed
• Conditions: Pharmacokinetics
• Intervention / Treatment: Drug: SVG101 (T); Drug: Afinitor (R)

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Yonsei University Healthcare System, Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I; 13 subjects will receive; First Dose: Afinitor 5mg, single dose; Wash out period : more than 10 days; Second Dose: SVG101 5mg, single dose	Drug: SVG101 (T); 5mg of SVG101; Drug: Afinitor (R); 5mg of Afinitor
Experimental: Group II; 13 subjects will receive; First Dose: SVG101 5mg, single dose; Wash out period : more than 10 days; Second Dose: Afinitor 5mg, single dose	Drug: SVG101 (T); 5mg of SVG101; Drug: Afinitor (R); 5mg of Afinitor

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse Events (AEs)	up to approximately 45 days

Collaborators and Investigators

• Sponsor: SoVarGen Co., Ltd.
• Investigators: Study Director: Eric J Maeng, SoVarGen Co., Ltd.

Publications and helpful links

General Publications

• Lim JS, Kim WI, Kang HC, Kim SH, Park AH, Park EK, Cho YW, Kim S, Kim HM, Kim JA, Kim J, Rhee H, Kang SG, Kim HD, Kim D, Kim DS, Lee JH. Brain somatic mutations in MTOR cause focal cortical dysplasia type II leading to intractable epilepsy. Nat Med. 2015 Apr;21(4):395-400. doi: 10.1038/nm.3824. Epub 2015 Mar 23.

Helpful Links

• Everolimus_Clinical Pharmacology Review

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2021
• Primary Completion (Actual): January 28, 2022
• Study Completion (Actual): February 7, 2022

Study Registration Dates

• First Submitted: August 2, 2022
• First Submitted That Met QC Criteria: August 3, 2022
• First Posted (Actual): August 5, 2022

Study Record Updates

• Last Update Posted (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 3, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Everolimus; Healthy adults; Disperse formulation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Everolimus
• Other Study ID Numbers: SVG101-P1-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No