Pharmacokinetic
Conditions
Brief 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. 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.
Interventions
DRUGStrength A Sublingual Minoxidil
One single dose of Strength A sublingual minoxidil
DRUGStrength B Sublingual Minoxidil
One single dose of Strength B sublingual minoxidil
Sponsors
Samson Clinical Operations Pty Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Terminal half-life (T½) of sublingual minoxidil | 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. |
| Area under the concentration-time profile (AUClast, AUCinf) of sublingual minoxidil | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Type of adverse events | At Day 1, Day 8, and Day 15 | 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. |
| Incidence of Adverse Events | At Day 1, Day 8, and Day 15 | 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. |
| Relationship of adverse events to study drug | At Day 1, Day 8, and Day 15 | 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. |
| Severity of adverse events | At Day 1, Day 8, and Day 15 | 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. |
| Change from baseline in clinical safety monitoring parameters | At Day 1, Day 8, and Day 15 | 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. |
Countries
Australia
Outcome results
None listed