Clinical trial NCT05490095: Randomized Crossover of SVG101(Dispersible Tab. of Everolimus) and Afinitor 5mg in Healthy Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Keywords: Everolimus
Healthy adults
Disperse formulation
Lead sponsor: SoVarGen Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-08-05
Enrollment: 26
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: AUCinf of everolimus
timeFrame: up to 144 hours
measure: Cmax of Everolimus
timeFrame: up to 144 hours
measure: Cmin,ss,pred of Everolimus
timeFrame: up to 144 hours
measure: AUClast of Everolimus
timeFrame: up to 144 hours
measure: Tmax of Everolimus
timeFrame: up to 144 hours
measure: t1/2 of Everolimus
timeFrame: up to 144 hours
measure: Vd/F of Everolimus
timeFrame: up to 144 hours
measure: Clearance of Everolimus
timeFrame: up to 144 hours
Secondary outcomes:
measure: Adverse Events (AEs)
timeFrame: up to approximately 45 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Healthcare System, Severance Hospital
Study officials:
affiliation: SoVarGen Co., Ltd.
name: Eric J Maeng
role: STUDY_DIRECTOR
References:
citation: 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.