A Phase 1 Randomized, Double Blind, Crossover Pharmacokinetic Study of Minoxidil Sublingual Tablets in Adult Male and Female Healthy Volunteers.

Samson Clinical Operations Pty Ltd1 site in 1 country12 target enrollmentNovember 6, 2024

ConditionsPharmacokinetic

InterventionsStrength A Sublingual Minoxidil Strength B Sublingual Minoxidil

DrugsStrength A Sublingual Minoxidil Strength B Sublingual Minoxidil

Overview

Phase: Phase 1
Intervention: Strength A Sublingual Minoxidil
Conditions: Pharmacokinetic
Sponsor: Samson Clinical Operations Pty Ltd
Enrollment: 12
Locations: 1
Primary Endpoint: Area under the concentration-time profile (AUClast, AUCinf) of sublingual minoxidil
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 6, 2024

End Date

December 23, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Samson Clinical Operations Pty Ltd

Responsible Party

Sponsor

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.

Arms & Interventions

Strength A Sublingual Minoxidil

Intervention: Strength A Sublingual Minoxidil

Strength B Sublingual Minoxidil

Intervention: Strength B Sublingual Minoxidil