PharmacokineticPhase 1NCT06679556
Phase 1 Pharmacokinetic Study of Minoxidil SL Tablets
A Phase 1 study testing Strength A Sublingual Minoxidil and Strength B Sublingual Minoxidil in people with Pharmacokinetic, run by Samson Clinical Operations Pty Ltd at 1 site in Australia.
Trial summary
This is a phase 1 randomized, double blind, crossover study examining the pharmacokinetic profile of two different doses of minoxidil sublingual tablets in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetic
- What is being tested?
- Strength A Sublingual Minoxidil and Strength B Sublingual Minoxidil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteAustralia
- Study dates
- 6 Nov 2024to 23 Dec 2024
- 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 and female subjects between 18 and 65 years of age (inclusive) at screening.
- In good general health in the opinion of the Investigator based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring (ECG). A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if, in the opinion of the Investigator, the finding is (a) unlikely to introduce additional risk to the subject, (b) will not interfere with study procedures or confound study results, and (c) is not listed in the Exclusion Criteria.
- Body mass index (BMI) is between 18.5 - 30.0 kg/m2 with a body weight of at least 50 kg.
- Have systolic blood pressure within normal limits (90-140 mm Hg).
- Have adequate venous access on their left or right arm to allow collection of multiple blood samples.
- Women of Childbearing Potential (WOCBP) must agree to use a highly effective method of contraception from enrolment to the safety follow-up visit.
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- Women of non-childbearing potential must be post-menopausal or permanently sterilised at least 6 months prior to screening.
- All WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test before dosing on each dosing day.
- Willing and able to attend all study visits and comply with treatment plan and required study procedures.
- Able to comprehend and willing to sign and date a written informed consent form.
Who cannot join
- History of hypersensitivity or allergies to any ingredients contained in the study medication.
- A positive urine drugs of abuse screen at Screening or alcohol breath test on dosing days, unless for a legitimate medical reason as determined by the Investigator.
- A positive Hepatitis B surface antigen, Hepatitis C antibody result, or human immunodeficiency virus (HIV) result at screening.
- Current participation in any other investigational drug or medical device trial, which includes administration of an investigational study medication or medical device, or within 3 months or 5 half-lives of the investigational product, whichever is longer, prior to receiving first dose.
- Unwilling to comply with all study procedures and assessments.
- Participants with specific underlying conditions (e.g. cardiovascular disease, cardiac arrhythmia, hepatic comorbidity, renal comorbidity, phaeochromocytoma), clinically significant findings from medical history, clinical laboratory tests, ECG, or vital signs that, in the opinion of the Investigator, could interfere with the objectives of the study or put the participant at risk.
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- Use of anti-hypertensive medication or any other medications that, in the opinion of the Investigator, could interfere with the objectives of the study or put the participant at risk, within 14 days or 5 half-lives (whichever is longer) before the start of the study treatment.
- A history of alcoholism, substance or drug abuse-related disorders in the past year as deemed significant by the Investigator.
- Pregnant, planning a pregnancy, or nursing a child.
- Major surgery within 4 weeks prior to the screening evaluation, or planned surgery prior to completion of all study procedures.
- Donation of blood or blood products of 470 mL or greater within 12 weeks prior to dosing in Period 1.
- Dietary requirements that prevent consumption of the standardised study meals.
- Poor complier or unlikely to attend specified study days.
- Study site or Sponsor employee, or immediate family member of a study site or Sponsor employee.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Randomized, Double Blind, Crossover Pharmacokinetic Study of Minoxidil Sublingual Tablets in Adult Male and Female Healthy Volunteers.
This is a phase 1 randomized, double blind, crossover study examining the pharmacokinetic profile of two different doses of minoxidil sublingual tablets in healthy adult volunteers.
The main objective is to determine the pharmacokinetics of minoxidil following sublingual administration of a single dose in adult male and female healthy volunteers. The secondary objective is to evaluate the safety of minoxidil following sublingual administration of a single dose in adult male and female healthy volunteers.
Read more
A total of 12 participants (6 male and 6 female) will be recruited for study participation.
The duration of study participation is up to 43 days including screening and safety follow up. A single dose of study medication (strength A or strength B) will be administered on Day 1 to all study participants and PK samples will be taken periodically over a 12-hr period. After at least 7-day washout period the other dose of study medication (strength B or strength A, respectively) will be administered to all participants and PK samples will be taken periodically over a 12-hr period.
- Conditions
- Pharmacokinetic
- Being tested
- Strength A Sublingual Minoxidil, Strength B Sublingual Minoxidil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength A Sublingual MinoxidilDrug
One single dose of Strength A sublingual minoxidil
Strength B Sublingual MinoxidilDrug
One single dose of Strength B sublingual minoxidil
| Study group | Role | What they receive |
|---|---|---|
| Strength A Sublingual Minoxidil | Experimental | Not described Receives: Drug: Strength A Sublingual Minoxidil |
| Strength B Sublingual Minoxidil | Experimental | Not described Receives: Drug: Strength B Sublingual Minoxidil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time profile (AUClast, AUCinf) of sublingual minoxidil
The primary endpoints will be the area under the concentration-time curve from time zero to the last measurable concentration (AUClast), the area under the concentration-time curve from time zero to infinity (AUCinf), maximum concentration (Cmax), time to maximum concentration (Tmax), half-life (T1/2), and the terminal rate constant (λz).
AUClast measures the total minoxidil exposure in the body up to the last measurable time point, while AUCinf estimates total minoxidil exposure from the time it's taken until it completely leaves the body.
Measured: At Day 1 and Day 8
Maximum observed concentration (Cmax) of sublingual minoxidil
The primary endpoints will be the area under the concentration-time curve from time zero to the last measurable concentration (AUClast), the area under the concentration-time curve from time zero to infinity (AUCinf), maximum concentration (Cmax), time to maximum concentration (Tmax), half-life (T1/2), and the terminal rate constant (λz).
Cmax is the highest concentration of minoxidil in the blood after it's taken.
Measured: At Day 1 and Day 8
Time of maximum observed concentration (Tmax) of sublingual minoxidil
The primary endpoints will be the area under the concentration-time curve from time zero to the last measurable concentration (AUClast), the area under the concentration-time curve from time zero to infinity (AUCinf), maximum concentration (Cmax), time to maximum concentration (Tmax), half-life (T1/2), and the terminal rate constant (λz).
Tmax measures the time it takes for minoxidil to reach its highest concentration in the blood after it's taken.
Measured: At Day 1 and Day 8
Terminal rate constant (λz) of sublingual minoxidil
The primary endpoints will be the area under the concentration-time curve from time zero to the last measurable concentration (AUClast), the area under the concentration-time curve from time zero to infinity (AUCinf), maximum concentration (Cmax), time to maximum concentration (Tmax), half-life (T1/2), and the terminal rate constant (λz).
The terminal rate constant measures the speed at which the concentration of minoxidil decreases in the blood during the last stage of elimination.
Measured: At Day 1 and Day 8
Terminal half-life (T½) of sublingual minoxidil
The primary endpoints will be the area under the concentration-time curve from time zero to the last measurable concentration (AUClast), the area under the concentration-time curve from time zero to infinity (AUCinf), maximum concentration (Cmax), time to maximum concentration (Tmax), half-life (T1/2), and the terminal rate constant (λz).
The terminal half-life measures the time it takes for the concentration of minoxidil in the blood to decrease by half during the last stage of elimination.
Measured: At Day 1 and Day 8
Secondary outcomes (5)
Type of adverse events
The safety profile of sublingual minoxidil will be evaluated by analyzing the type, incidence, relationship to study drug and severity of adverse events for each dose of sublingual minoxidil. It will also be evaluated through the change from baseline in clinical safety monitoring parameters, including clinical laboratory tests, vital signs, and ECG.
Measured: At Day 1, Day 8, and Day 15
Incidence of Adverse Events
The safety profile of sublingual minoxidil will be evaluated by analyzing the type, incidence, relationship to study drug and severity of adverse events for each dose of sublingual minoxidil. It will also be evaluated through the change from baseline in clinical safety monitoring parameters, including clinical laboratory tests, vital signs, and ECG.
Measured: At Day 1, Day 8, and Day 15
Relationship of adverse events to study drug
The safety profile of sublingual minoxidil will be evaluated by analyzing the type, incidence, relationship to study drug and severity of adverse events for each dose of sublingual minoxidil. It will also be evaluated through the change from baseline in clinical safety monitoring parameters, including clinical laboratory tests, vital signs, and ECG.
Measured: At Day 1, Day 8, and Day 15
Severity of adverse events
The safety profile of sublingual minoxidil will be evaluated by analyzing the type, incidence, relationship to study drug and severity of adverse events for each dose of sublingual minoxidil. It will also be evaluated through the change from baseline in clinical safety monitoring parameters, including clinical laboratory tests, vital signs, and ECG.
Measured: At Day 1, Day 8, and Day 15
Change from baseline in clinical safety monitoring parameters
The safety profile of sublingual minoxidil will be evaluated by analyzing the type, incidence, relationship to study drug and severity of adverse events for each dose of sublingual minoxidil. It will also be evaluated through the change from baseline in clinical safety monitoring parameters, including clinical laboratory tests, vital signs, and ECG.
Measured: At Day 1, Day 8, and Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start6 Nov 2024
- Primary completion23 Dec 2024
- Study completion23 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samson Clinical Operations Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06679556
- Sponsor's protocol ID
- SAM-001
- Status last verified
- Feb 2025
- First submitted
- 21 Oct 2024
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Double Blind, Crossover Pharmacokinetic Study of Minoxidil Sublingual Tablets in Adult Male and Female Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT06679556
- Acronym / sponsor ID
- SAM-001
- Conditions
- Pharmacokinetic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Samson Clinical Operations Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- 23 Dec 2024 (actual)
- Study completion
- 23 Dec 2024 (actual)
- First posted
- 7 Nov 2024 (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 is a phase 1 randomized, double blind, crossover study examining the pharmacokinetic profile of two different doses of minoxidil sublingual tablets in healthy adult volunteers.
The main objective is to determine the pharmacokinetics of minoxidil following sublingual administration of a single dose in adult male and female healthy volunteers. The secondary objective is to evaluate the safety of minoxidil following sublingual administration of a single dose in adult male and female healthy volunteers.
A total of 12 participants (6 male and 6 female) will be recruited for study participation.
The duration of study participation is up to 43 days including screening and safety follow up. A single dose of study medication (strength A or strength B) will be administered on Day 1 to all study participants and PK samples will be taken periodically over a 12-hr period. After at least 7-day washout period the other dose of study medication (strength B or strength A, respectively) will be administered to all participants and PK samples will be taken periodically over a 12-hr period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strength A Sublingual Minoxidil | Experimental | Drug: Strength A Sublingual Minoxidil |
| Strength B Sublingual Minoxidil | Experimental | Drug: Strength B Sublingual Minoxidil |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male and female subjects between 18 and 65 years of age (inclusive) at screening.
- In good general health in the opinion of the Investigator based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring (ECG). A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if, in the opinion of the Investigator, the finding is (a) unlikely to introduce additional risk to the subject, (b) will not interfere with study procedures or confound study results, and (c) is not listed in the Exclusion Criteria.
- Body mass index (BMI) is between 18.5 - 30.0 kg/m2 with a body weight of at least 50 kg.
- Have systolic blood pressure within normal limits (90-140 mm Hg).
- Have adequate venous access on their left or right arm to allow collection of multiple blood samples.
Key exclusion criteria (14 listed)
- History of hypersensitivity or allergies to any ingredients contained in the study medication.
- A positive urine drugs of abuse screen at Screening or alcohol breath test on dosing days, unless for a legitimate medical reason as determined by the Investigator.
- A positive Hepatitis B surface antigen, Hepatitis C antibody result, or human immunodeficiency virus (HIV) result at screening.
- Current participation in any other investigational drug or medical device trial, which includes administration of an investigational study medication or medical device, or within 3 months or 5 half-lives of the investigational product, whichever is longer, prior to receiving first dose.
- Unwilling to comply with all study procedures and assessments.
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 |
|---|---|---|
| Strength A Sublingual MinoxidilOne single dose of Strength A sublingual minoxidil | Drug | Strength A Sublingual Minoxidil |
| Strength B Sublingual MinoxidilOne single dose of Strength B sublingual minoxidil | Drug | Strength B Sublingual Minoxidil |
Primary outcome
Area under the concentration-time profile (AUClast, AUCinf) of sublingual minoxidil
Time frame: At Day 1 and Day 8
The primary endpoints will be the area under the concentration-time curve from time zero to the last measurable concentration (AUClast), the area under the concentration-time curve from time zero to infinity (AUCinf), maximum concentration (Cmax), time to maximum concentration (Tmax), half-life (T1/2), and the terminal rate constant (λz). AUClast measures the total minoxidil exposure in the body up to the last measurable time point, while AUCinf estimates total minoxidil exposure from the time it's taken until it completely leaves the body.
Maximum observed concentration (Cmax) of sublingual minoxidil
Time frame: At Day 1 and Day 8
The primary endpoints will be the area under the concentration-time curve from time zero to the last measurable concentration (AUClast), the area under the concentration-time curve from time zero to infinity (AUCinf), maximum concentration (Cmax), time to maximum concentration (Tmax), half-life (T1/2), and the terminal rate constant (λz). Cmax is the highest concentration of minoxidil in the blood after it's taken.
Time of maximum observed concentration (Tmax) of sublingual minoxidil
Time frame: At Day 1 and Day 8
The primary endpoints will be the area under the concentration-time curve from time zero to the last measurable concentration (AUClast), the area under the concentration-time curve from time zero to infinity (AUCinf), maximum concentration (Cmax), time to maximum concentration (Tmax), half-life (T1/2), and the terminal rate constant (λz). Tmax measures the time it takes for minoxidil to reach its highest concentration in the blood after it's taken.
Terminal rate constant (λz) of sublingual minoxidil
Time frame: At Day 1 and Day 8
The primary endpoints will be the area under the concentration-time curve from time zero to the last measurable concentration (AUClast), the area under the concentration-time curve from time zero to infinity (AUCinf), maximum concentration (Cmax), time to maximum concentration (Tmax), half-life (T1/2), and the terminal rate constant (λz). The terminal rate constant measures the speed at which the concentration of minoxidil decreases in the blood during the last stage of elimination.
Terminal half-life (T½) of sublingual minoxidil
Time frame: At Day 1 and Day 8
The primary endpoints will be the area under the concentration-time curve from time zero to the last measurable concentration (AUClast), the area under the concentration-time curve from time zero to infinity (AUCinf), maximum concentration (Cmax), time to maximum concentration (Tmax), half-life (T1/2), and the terminal rate constant (λz). The terminal half-life measures the time it takes for the concentration of minoxidil in the blood to decrease by half during the last stage of elimination.
5 secondary outcomes
Type of adverse events
Time frame: At Day 1, Day 8, and Day 15
Incidence of Adverse Events
Time frame: At Day 1, Day 8, and Day 15
Relationship of adverse events to study drug
Time frame: At Day 1, Day 8, and Day 15
Severity of adverse events
Time frame: At Day 1, Day 8, and Day 15
Change from baseline in clinical safety monitoring parameters
Time frame: At Day 1, Day 8, and Day 15
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 17 Feb 2025.
- Individual participant dataSharing planned: No
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Healthy Participants
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 Strength A Sublingual Minoxidil and Strength B Sublingual Minoxidil in people with Pharmacokinetic, run by Samson Clinical Operations Pty Ltd at 1 site in Australia.
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 10 inclusion and 14 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 17 Feb 2025. 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 Australia. 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?
Area under the concentration-time profile (AUClast, AUCinf) of sublingual minoxidil (time frame: At Day 1 and Day 8). The study lists 5 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 17 Feb 2025.