Phase 1 Pharmacokinetic Study of Minoxidil SL Tablets

NCT06679556 | Completed Phase 1

• 1 other identifier: SAM-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacokinetic

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  At Day 1 and Day 8

Secondary Outcomes (5)

• Type of adverse events

  At Day 1, Day 8, and Day 15

• Incidence of Adverse Events

  At Day 1, Day 8, and Day 15

• Relationship of adverse events to study drug

  At Day 1, Day 8, and Day 15

• Severity of adverse events

  At Day 1, Day 8, and Day 15

• Change from baseline in clinical safety monitoring parameters

  At Day 1, Day 8, and Day 15

Study Arms (2)

Strength A Sublingual Minoxidil

EXPERIMENTAL

Drug: Strength A Sublingual Minoxidil

Strength B Sublingual Minoxidil

EXPERIMENTAL

Drug: Strength B Sublingual Minoxidil

Interventions

Strength A Sublingual Minoxidil DRUG

One single dose of Strength A sublingual minoxidil

Strength A Sublingual Minoxidil

Strength B Sublingual Minoxidil DRUG

One single dose of Strength B sublingual minoxidil

Strength B Sublingual Minoxidil

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects between 18 and 65 years of age (inclusive) at screening.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Samson Clinical Operations Pty Ltd: lead

Study Sites (1)

Dr Rodney Sinclair Pty Ltd

East Melbourne, Victoria, 3002, Australia

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: November 7, 2024
• Study Start: November 6, 2024
• Primary Completion: December 23, 2024
• Study Completion: December 23, 2024
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)