PharmacokineticsPhase 1NCT05490095
Randomized Crossover of SVG101(Dispersible Tab. of Everolimus) and Afinitor 5mg in Healthy Adults
A Phase 1 study testing SVG101 (T) and Afinitor (R) in people with Pharmacokinetics, run by Sovargen at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- SVG101 (T) and Afinitor (R)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Jul 2021to 7 Feb 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Healthcare System, Severance Hospital
Seoul
About this study
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
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.
Read the 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.
- Conditions
- Pharmacokinetics
- Being tested
- SVG101 (T), Afinitor (R)
- Keywords
- Everolimus, Healthy adults, Disperse formulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SVG101 (T)Drug
5mg of SVG101
Afinitor (R)Drug
5mg of Afinitor
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: SVG101 (T); Drug: Afinitor (R) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCinf of everolimus
Measured: up to 144 hours
Cmax of Everolimus
Measured: up to 144 hours
Cmin,ss,pred of Everolimus
Measured: up to 144 hours
AUClast of Everolimus
Measured: up to 144 hours
Tmax of Everolimus
Measured: up to 144 hours
t1/2 of Everolimus
Measured: up to 144 hours
Vd/F of Everolimus
Measured: up to 144 hours
Clearance of Everolimus
Measured: up to 144 hours
Secondary outcomes (1)
Adverse Events (AEs)
Measured: up to approximately 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start23 Jul 2021
- Primary completion28 Jan 2022
- Study completion7 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sovargen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric J Maeng, Study director, Sovargen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490095
- Sponsor's protocol ID
- SVG101-P1-01
- Status last verified
- Aug 2022
- First submitted
- 2 Aug 2022
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25799227
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05490095
- Acronym / sponsor ID
- SVG101-P1-01
- Conditions
- Pharmacokinetics
- Keywords
- Everolimus, Healthy adults, Disperse formulation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- SovargenIndustry (pharma, biotech, devices)
- Study start
- 23 Jul 2021 (actual)
- Primary completion
- 28 Jan 2022 (actual)
- Study completion
- 7 Feb 2022 (actual)
- First posted
- 5 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Drug: SVG101 (T), Drug: Afinitor (R)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 |
| Group II | Experimental | Drug: SVG101 (T), Drug: Afinitor (R)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 |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SVG101 (T)5mg of SVG101 | Drug | Group I, Group II |
| Afinitor (R)5mg of Afinitor | Drug | Group I, Group II |
Primary outcome
AUCinf of everolimus
Time frame: up to 144 hours
Cmax of Everolimus
Time frame: up to 144 hours
Cmin,ss,pred of Everolimus
Time frame: up to 144 hours
AUClast of Everolimus
Time frame: up to 144 hours
Tmax of Everolimus
Time frame: up to 144 hours
t1/2 of Everolimus
Time frame: up to 144 hours
Vd/F of Everolimus
Time frame: up to 144 hours
Clearance of Everolimus
Time frame: up to 144 hours
1 secondary outcome
Adverse Events (AEs)
Time frame: up to approximately 45 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Background: PubMed 25799227Lim 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.
- Everolimus\_Clinical Pharmacology ReviewLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric J Maeng study director
Sovargen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SVG101 (T) and Afinitor (R) in people with Pharmacokinetics, run by Sovargen at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCinf of everolimus (time frame: up to 144 hours). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05490095, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.