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

• Sponsor: SoVarGen Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05490095
• Collaborator: (none)
• Enrollment: 26
• Location: 1
• Arms: 2
• Actual Duration (Months): 6.5
• Patients Per Site Per Month: 4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pharmacokinetics	Drug: SVG101 (T); Drug: Afinitor (R)	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Jul 23, 2021
• Actual Primary Completion Date: Jan 28, 2022
• Actual Study Completion Date: Feb 7, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. AUCinf of everolimus [up to 144 hours]

2. Cmax of Everolimus [up to 144 hours]

3. Cmin,ss,pred of Everolimus [up to 144 hours]

4. AUClast of Everolimus [up to 144 hours]

5. Tmax of Everolimus [up to 144 hours]

6. t1/2 of Everolimus [up to 144 hours]

7. Vd/F of Everolimus [up to 144 hours]

8. Clearance of Everolimus [up to 144 hours]

Secondary Outcome Measures

1. Adverse Events (AEs) [up to approximately 45 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yonsei University Healthcare System, Severance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• SoVarGen Co., Ltd.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Everolimus_Clinical Pharmacology Review

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.

• Responsible Party: SoVarGen Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05490095
• Other Study ID Numbers: SVG101-P1-01
• First Posted: Aug 5, 2022
• Last Update Posted: Aug 5, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by SoVarGen Co., Ltd.: Everolimus; Healthy adults; Disperse formulation
• Additional relevant MeSH terms: Everolimus

Study Results

No Results Posted as of Aug 5, 2022