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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06679556




Registration number
NCT06679556
Ethics application status
Date submitted
21/10/2024
Date registered
7/11/2024

Titles & IDs
Public title
Phase 1 Pharmacokinetic Study of Minoxidil SL Tablets
Scientific title
A Phase 1 Randomized, Double Blind, Crossover Pharmacokinetic Study of Minoxidil Sublingual Tablets in Adult Male and Female Healthy Volunteers.
Secondary ID [1] 0 0
SAM-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pharmacokinetic 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Strength A Sublingual Minoxidil
Treatment: Drugs - Strength B Sublingual Minoxidil

Experimental: Strength A Sublingual Minoxidil -

Experimental: Strength B Sublingual Minoxidil -


Treatment: Drugs: Strength A Sublingual Minoxidil
One single dose of Strength A sublingual minoxidil

Treatment: Drugs: Strength B Sublingual Minoxidil
One single dose of Strength B sublingual minoxidil
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area under the concentration-time profile (AUClast, AUCinf) of sublingual minoxidil
Timepoint [1] 0 0
At Day 1 and Day 8
Primary outcome [2] 0 0
Maximum observed concentration (Cmax) of sublingual minoxidil
Timepoint [2] 0 0
At Day 1 and Day 8
Primary outcome [3] 0 0
Time of maximum observed concentration (Tmax) of sublingual minoxidil
Timepoint [3] 0 0
At Day 1 and Day 8
Primary outcome [4] 0 0
Terminal rate constant (?z) of sublingual minoxidil
Timepoint [4] 0 0
At Day 1 and Day 8
Primary outcome [5] 0 0
Terminal half-life (T½) of sublingual minoxidil
Timepoint [5] 0 0
At Day 1 and Day 8
Secondary outcome [1] 0 0
Type of adverse events
Timepoint [1] 0 0
At Day 1, Day 8, and Day 15
Secondary outcome [2] 0 0
Incidence of Adverse Events
Timepoint [2] 0 0
At Day 1, Day 8, and Day 15
Secondary outcome [3] 0 0
Relationship of adverse events to study drug
Timepoint [3] 0 0
At Day 1, Day 8, and Day 15
Secondary outcome [4] 0 0
Severity of adverse events
Timepoint [4] 0 0
At Day 1, Day 8, and Day 15
Secondary outcome [5] 0 0
Change from baseline in clinical safety monitoring parameters
Timepoint [5] 0 0
At Day 1, Day 8, and Day 15

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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.



* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/11/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Dr Rodney Sinclair Pty Ltd - East Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Samson Clinical Operations Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06679556