NCT05490095

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2021

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 23, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 5, 2022

Completed
Last Updated

August 5, 2022

Status Verified

August 1, 2022

Enrollment Period

6 months

First QC Date

August 2, 2022

Last Update Submit

August 3, 2022

Conditions

Pharmacokinetics

Keywords

EverolimusHealthy adultsDisperse formulation

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (1)

  • Adverse Events (AEs)

    up to approximately 45 days

Study Arms (2)

Group I

EXPERIMENTAL

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

Drug: SVG101 (T)Drug: Afinitor (R)

Group II

EXPERIMENTAL

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

Drug: SVG101 (T)Drug: Afinitor (R)

Interventions

SVG101 (T)DRUG

5mg of SVG101

Group IGroup II
Afinitor (R)DRUG

5mg of Afinitor

Group IGroup II

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.
  • Participants with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
  • Any history of gastrointestinal disease or surgery
  • Participants have hypersensitive to the everolimus or other rapamycin derivatives or other components of the investigational product.
  • Taking any drugs that induce or inhibit metabolizing enzymes such as barbiturate drugs within 30 days prior to first administration
  • 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
  • Pregnant or breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University Healthcare System, Severance Hospital

Seoul, South Korea

Location

Related 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.

    PMID: 25799227BACKGROUND

Related Links

MeSH Terms

Interventions

Everolimus

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Study Officials

  • Eric J Maeng

    Sovargen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2022

First Posted

August 5, 2022

Study Start

July 23, 2021

Primary Completion

January 28, 2022

Study Completion

February 7, 2022

Last Updated

August 5, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)