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

Pharmacokinetics Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05490095
• Other study ID #: SVG101-P1-01
• Status: Completed
• Phase: Phase 1
• Start date: July 23, 2021
• Est. completion date: February 7, 2022

Study information

• Verified date: August 2022
• Source: SoVarGen Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: February 7, 2022
• Est. primary completion date: January 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Drug:
• SVG101 (T)
5mg of SVG101
• Afinitor (R)
5mg of Afinitor

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Healthcare System, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
SoVarGen Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCinf of everolimus		up to 144 hours
Primary	Cmax of Everolimus		up to 144 hours
Primary	Cmin,ss,pred of Everolimus		up to 144 hours
Primary	AUClast of Everolimus		up to 144 hours
Primary	Tmax of Everolimus		up to 144 hours
Primary	t1/2 of Everolimus		up to 144 hours
Primary	Vd/F of Everolimus		up to 144 hours
Primary	Clearance of Everolimus		up to 144 hours
Secondary	Adverse Events (AEs)		up to approximately 45 days

External Links

•   Everolimus_Clinical Pharmacology Review