Bioavailability StudyPhase 1NCT03972462
NPC-12G Gel 0.2% Sirolimus PK Bridging Study
A Phase 1 study testing NPC-12G Gel 0.2% and Rapamune® 2 mg tablet in people with Bioavailability Study, run by Nobelpharma at 1 site in United States.
Trial summary
This study is designed to describe the relative systemic bioavailability of topical and oral sirolimus formulations. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability Study
- What is being tested?
- NPC-12G Gel 0.2% and Rapamune® 2 mg tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2019to 17 Jun 2019
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, non-smoker (no use within 3 months prior to screening), ≥ 18 and ≤ 65 years of age, with BMI > 18.5 and < 30.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females
- Females of childbearing potential who are sexually active with a male partner must be willing to use one of acceptable contraceptive method throughout the study and for 12 weeks after the last study drug administration
Who cannot join
- Any sign of eczema/dermatitis, skin lesion, wound, or infection at the application site, or any other conditions that would prevent a safe application of the gel formulation.
- Laser or surgery at the gel application site within 2 weeks before the gel application.
- Positive alcohol breath test, urine drug screen or urine cotinine test at screeningation
- History of allergic reactions or hypersensitivity to sirolimus, sirolimus derivatives, or excipient of NPC-12G Gel
- Use of any drugs known to induce or inhibit CYP3A4 metabolism within 30 days prior to the first study drug administration
- Positive pregnancy test at screening
Show all 10Show fewer
- Breast-feeding subject
- History of active tuberculosis or exposure to endemic areas within 8 weeks prior to QuantiFERON®-TB testing performed at screening
- Positive QuantiFERON®-TB test with positive chest X-ray, indicating possible tuberculosis infection
- Immunization with a live attenuated vaccine within 1 month prior to dosing or planned vaccination during the study and up to 3 weeks after the last study drug administration
Trial locations and contacts
1 site in 1 country.
United States1 site
InVentiv Health Clinical Research Services LLC
Miami, Florida, 33136
About this study
Official title: Open-label, Fixed-sequence, Two-period Comparative Bioavailability Study of Sirolimus From Topical Application of NPC-12G Gel to Oral Rapamune® Following Single Administration in Healthy Subjects Under Fasting Conditions
This study is designed to describe the relative systemic bioavailability of topical and oral sirolimus formulations.
- Conditions
- Bioavailability Study
- Being tested
- NPC-12G Gel 0.2%, Rapamune® 2 mg tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPC-12G Gel 0.2%Drug
Also called 2 mg of sirolimus in 1 g of gel
Period 1
Rapamune® 2 mg tabletDrug
Also called Sirolimus
Period 2
| Study group | Role | What they receive |
|---|---|---|
| NPC-12G Gel 0.2% (Period 1) | Experimental | A single 800 mg quantity weight (1.6 mg sirolimus) dose will be applied to the central face on Day 1. Receives: Drug: NPC-12G Gel 0.2% |
| Rapamune Tablet (Period 2) | Active comparator | Rapamune® (sirolimus) 2 mg tablet for oral dosing. Receives: Drug: Rapamune® 2 mg tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-48
Measured: Sampling: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 hours post-dose
Cmax
Measured: Sampling: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 hours post-dose
Tmax
Measured: Sampling: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start31 May 2019
- Primary completion17 Jun 2019
- Study completion17 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioavailability StudyStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nobelpharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03972462
- Sponsor's protocol ID
- NPC-12G-4/US
- Status last verified
- May 2019
- First submitted
- 24 May 2019
- Last updated
- 6 Mar 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Fixed-sequence, Two-period Comparative Bioavailability Study of Sirolimus From Topical Application of NPC-12G Gel to Oral Rapamune® Following Single Administration in Healthy Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT03972462
- Acronym / sponsor ID
- NPC-12G-4/US
- Conditions
- Bioavailability Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- NobelpharmaIndustry (pharma, biotech, devices)
- Study start
- 31 May 2019 (actual)
- Primary completion
- 17 Jun 2019 (actual)
- Study completion
- 17 Jun 2019 (actual)
- First posted
- 3 Jun 2019 (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.
This study is designed to describe the relative systemic bioavailability of topical and oral sirolimus formulations.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NPC-12G Gel 0.2% (Period 1) | Experimental | Drug: NPC-12G Gel 0.2%A single 800 mg quantity weight (1.6 mg sirolimus) dose will be applied to the central face on Day 1. |
| Rapamune Tablet (Period 2) | Active comparator | Drug: Rapamune® 2 mg tabletRapamune® (sirolimus) 2 mg tablet for oral dosing. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female, non-smoker (no use within 3 months prior to screening), ≥ 18 and ≤ 65 years of age, with BMI > 18.5 and < 30.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females
- Females of childbearing potential who are sexually active with a male partner must be willing to use one of acceptable contraceptive method throughout the study and for 12 weeks after the last study drug administration
Key exclusion criteria (10 listed)
- Any sign of eczema/dermatitis, skin lesion, wound, or infection at the application site, or any other conditions that would prevent a safe application of the gel formulation.
- Laser or surgery at the gel application site within 2 weeks before the gel application.
- Positive alcohol breath test, urine drug screen or urine cotinine test at screeningation
- History of allergic reactions or hypersensitivity to sirolimus, sirolimus derivatives, or excipient of NPC-12G Gel
- Use of any drugs known to induce or inhibit CYP3A4 metabolism within 30 days prior to the first study drug 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 |
|---|---|---|
| NPC-12G Gel 0.2%Also: 2 mg of sirolimus in 1 g of gelPeriod 1 | Drug | NPC-12G Gel 0.2% (Period 1) |
| Rapamune® 2 mg tabletAlso: SirolimusPeriod 2 | Drug | Rapamune Tablet (Period 2) |
Primary outcome
AUC0-48
Time frame: Sampling: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 hours post-dose
Cmax
Time frame: Sampling: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 hours post-dose
Tmax
Time frame: Sampling: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 hours post-dose
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 6 Mar 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 NPC-12G Gel 0.2% and Rapamune® 2 mg tablet in people with Bioavailability Study, run by Nobelpharma at 1 site in United States.
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 2 inclusion and 10 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 6 Mar 2020. 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 United States. 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?
AUC0-48 (time frame: Sampling: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 hours post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2020.