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Trial registered on ANZCTR


Registration number
ACTRN12623000261617
Ethics application status
Approved
Date submitted
13/02/2023
Date registered
10/03/2023
Date last updated
14/01/2024
Date data sharing statement initially provided
10/03/2023
Date results information initially provided
14/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase I, Open-Label Study to Evaluate the Safety and Pharmacokinetics of APC201 in Healthy Volunteers
Scientific title
A Phase I, Open-Label Study to Evaluate the Safety and Pharmacokinetics of APC201 in Healthy Volunteers
Secondary ID [1] 308989 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain associated with osteoarthritis of the knee 329015 0
Anaesthesiology 329136 0
Condition category
Condition code
Anaesthesiology 325997 325997 0 0
Pain management
Musculoskeletal 326179 326179 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Apply APC201 topically twice daily on both knees for 1 week, a participant’s adherence to the assigned treatment plan will be assessed by reviewing entries on his/her diary card at each return visit.
The intended dose of APC201 per administration is 3 actuations (0.75 mL x 3), equivalent to 94 mg of diclofenac sodium per knee for each administration.
Intervention code [1] 325431 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333853 0
Incidence of AEs graded using Common Terminology Criteria for Adverse Events (CTCAE 5.0)
Timepoint [1] 333853 0
Assessed at every study visit, from Visit 2 (Day 1), Visit 3, 4, 5 (Day 5, 6, 7) to Visit 6 (Day 8) post-commencement of intervention.
Primary outcome [2] 333980 0
Skin irritation assessed using an ordinal scale (0-4 where 0 represented no visible reaction and 4 represented erythema with induration and bullae)
Timepoint [2] 333980 0
Assessed at every study visit, from Visit 2 (Day 1), Visit 3, 4, 5 (Day 5, 6, 7) to Visit 6 (Day 8) post-commencement of intervention.
Secondary outcome [1] 418474 0
Blood sampling for pharmacokinetic analysis, include Cmaxss, Tmaxss, AUC, half-life t1/2 and plasma elimination rate constant Kel
Timepoint [1] 418474 0
PK will be performed at the following time points: 0.0 h (pre-dose), 0.5, 1.0, 2.0, 4.0, 6.0, 8.0, 12.0 h post-dose on Day 1; 0.0 h (pre-dose) on Days 5-7; and 0.0 h (pre-dose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, 10.0, 12.0, 24.0 h post-dose on Days 8-9

Eligibility
Key inclusion criteria
1. Male or female adult, 18 to 85 years of age, inclusive at the time of screening.
2. If female of childbearing potential, subject must be not pregnant as assessed by a pregnancy test at screening and agree to use an acceptable method of contraception (progestogen-only hormonal contraception, where inhibition of ovulation is not the primary mode of action, male or female condom with or without spermicide, cap, diaphragm or sponge with spermicide) from enrolment up to 30 days after the study end. Female subject being postmenopausal for at least 1 year or surgically sterile is considered to be of no childbearing potential.
3. The subject has a body mass index (BMI) is greater than or equal to 18.5 and less than 40.
4. The health status is assessed by the investigator as “normal healthy” based on required screening assessments.
5. The subject provided written informed consent.
6. Subject agrees to maintain the usual activity level throughout the course of the study.
7. Subject must agree to not showering, swimming or wetting the treated knee(s) for 2 hours post application.
8. Subject must agree to avoid exposing the treated knee(s) to natural or artificial sunlight.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Known or suspected hypersensitivity to NSAIDs (non-steroidal anti-inflammatory drugs), any of the components in either of the investigational products (IPs), or any physical impediment to apply IP on the knees.
2. Known presence of gastrointestinal ulcer or any gastrointestinal bleeding within 6 months prior to Day 1.
3. Surgery or arthroscopy of knee(s) within one year prior to Day 1.
5. Skin disorder that affects palms of the hands or the application site of the knee(s).
6. History of diabetes.
7. Donation or significant loss of blood (480 mL or more) within 60 days prior to Day 1.
8. Administration of an investigational drug within 30 days prior to Day 1.
10. Subject treated with systemic or local NSAIDs within 30 days prior to Day 1.
11. Smoked or used nicotine-containing products within 6 months prior to Day 1.
12. Has used cannabis or any CBD or THC-containing product within 30 days of the screening visit and during the study.
13. Subject plans to use any OTC cosmetic tanning lotions to the target knee while on study.
14. Abnormal hepatic and renal functions; hematologic changes at screening:
The value of Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) is greater than or equal to 2.5 times upper limit of normal;
The value of Total bilirubin is greater than or equal to 1.5 times upper limit of normal;
The value of Serum creatinine is greater than or equal to 1.5 times upper limit of normal;
The value of Hemoglobin is less than or equal to lower limit of normal.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis
Analysis Sets
Per-protocol (PP) population: all study subjects who have taken at least one dose of study product and had no major protocol violation.
Safety Population: all study patients who have taken at least one dose of the study medications.
Statistical Analyses:
PK parameters (Cmaxss, Tmaxss, AUC, half-life t1/2 and plasma elimination rate constant Kel) will be individually listed and summarized using descriptive statistics (n, mean, geometric mean, SD, coefficient of variation as a percentage [CV%], median, minimum, maximum). PK parameter estimates will be estimated on the PK population using elapsed time calculated from actual dosing and sampling times.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/07/2023
Actual
20/10/2023
Date of last participant enrolment
Anticipated
11/08/2023
Actual
17/11/2023
Date of last data collection
Anticipated
Actual
1/12/2023
Sample size
Target
10
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 313201 0
Commercial sector/Industry
Name [1] 313201 0
Andros Pharmaceuticals Pty Ltd
Country [1] 313201 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Andros Pharmaceuticals Pty Ltd
Address
Level 7, 330 Collins Street, Melbourne Victoria 3000
Country
Australia
Secondary sponsor category [1] 314918 0
None
Name [1] 314918 0
Address [1] 314918 0
Country [1] 314918 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312433 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 312433 0
123 Glen Osmond Rd, Eastwood SA 5063
Ethics committee country [1] 312433 0
Australia
Date submitted for ethics approval [1] 312433 0
26/04/2023
Approval date [1] 312433 0
06/06/2023
Ethics approval number [1] 312433 0
2023-01-069

Summary
Brief summary
The purpose of phase 1 study is to evaluate the Pharmacokinetics, Safety, Tolerability of APC201 in Healthy Adults.
Trial website
Trial related presentations / publications
Public notes
key exclusion criteria:
4. Evidence of any serious active infections, COVID 19, severe uncontrolled cardiac, renal, hepatic, pulmonary or other systemic disease, significant medical or psychiatric condition, known seropositivity to HIV, known unexplained vision changes, history of unexplained syncope, lightheadedness, high blood pressure, chronic hepatic conditions like hepatic porphyria or clinically significant laboratory findings that would, in the investigator’s judgment, make the subject inappropriate for the study.
9. Administration of a COVID-19 vaccine within 30 days prior to Day 1.

Contacts
Principal investigator
Name 124650 0
Dr Indika Preethimal Leelasena
Address 124650 0
UniSc Clinical Trials, Morayfield.
Level 1/19-31 Dickson Rd, Morayfield Qld 4506
Country 124650 0
Australia
Phone 124650 0
+61 481127484
Fax 124650 0
Email 124650 0
[email protected]
Contact person for public queries
Name 124651 0
Ae-June Wang
Address 124651 0
Andros Pharmaceuticals Co., Ltd.
6F, No. 22, Sec. 2, Shengyi Rd., Zhubei City, Hsinchu County 30261, Taiwan
Country 124651 0
Taiwan, Province Of China
Phone 124651 0
+88636581866
Fax 124651 0
Email 124651 0
[email protected]
Contact person for scientific queries
Name 124652 0
Ya-Ying Lin
Address 124652 0
Andros Pharmaceuticals Co., Ltd.
6F, No. 22, Sec. 2, Shengyi Rd., Zhubei City, Hsinchu County 30261, Taiwan
Country 124652 0
Taiwan, Province Of China
Phone 124652 0
+88636581866
Fax 124652 0
Email 124652 0
[email protected]

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

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo No S/AEs. No significant AEs and none related to... [More Details]

Documents added automatically
No additional documents have been identified.