Clinical trial NCT06679556: Phase 1 Pharmacokinetic Study of Minoxidil SL Tablets
Official title: A Phase 1 Randomized, Double Blind, Crossover Pharmacokinetic Study of Minoxidil Sublingual Tablets in Adult Male and Female Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetic
Lead sponsor: Samson Clinical Operations Pty Ltd
Sponsor class: INDUSTRY
First posted: 2024-11-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Area under the concentration-time profile (AUClast, AUCinf) of sublingual minoxidil
timeFrame: At Day 1 and Day 8
measure: Maximum observed concentration (Cmax) of sublingual minoxidil
timeFrame: At Day 1 and Day 8
measure: Time of maximum observed concentration (Tmax) of sublingual minoxidil
timeFrame: At Day 1 and Day 8
measure: Terminal rate constant (λz) of sublingual minoxidil
timeFrame: At Day 1 and Day 8
measure: Terminal half-life (T½) of sublingual minoxidil
timeFrame: At Day 1 and Day 8
Secondary outcomes:
measure: Type of adverse events
timeFrame: At Day 1, Day 8, and Day 15
measure: Incidence of Adverse Events
timeFrame: At Day 1, Day 8, and Day 15
measure: Relationship of adverse events to study drug
timeFrame: At Day 1, Day 8, and Day 15
measure: Severity of adverse events
timeFrame: At Day 1, Day 8, and Day 15
measure: Change from baseline in clinical safety monitoring parameters
timeFrame: At Day 1, Day 8, and Day 15
Other outcomes:
Locations:
city: East Melbourne
country: Australia
facility: Dr Rodney Sinclair Pty Ltd
state: Victoria
Study officials:
References: