Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000895482p
Ethics application status
Submitted, not yet approved
Date submitted
7/08/2025
Date registered
18/08/2025
Date last updated
18/08/2025
Date data sharing statement initially provided
18/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of oral PRX-101 in healthy participants (Part 2)
Scientific title
A Phase 1b, single-center, randomized, two-part study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of oral PRX-101 in healthy participants
Secondary ID [1] 315085 0
PRX-101-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
paroxysmal supraventricular tachycardia 338482 0
Condition category
Condition code
Cardiovascular 334784 334784 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Part 2 has two stages. It is estimated that 18 to 48 participants will be enrolled in Part 2. The final number of participants and the dose of PRX-101 will be determined based on the data from Part 1. In Stage 1 participants will be randomized to one of three sequences with the selected dose of PRX-101 (Dose A) given under fed and fasted conditions and after administration of a 10mg IV dose of verapamil HCl (V). The three drug sequences for Part 2 are Dose A Fed – V – Dose A Fasted, Dose A Fasted - Dose A Fed – V, and V – Dose A Fasted – Dose A Fed. All participants will receive a single dose of study drug on Day 1, Day 3 and Day 5 according to their assigned sequence. All participants from Stage 1 will then proceed into Stage 2 where on Day 7 the participants will receive two doses of PRX-101 (Dose A) given under fasted conditions and separated by 30 minutes. On Day 8 participants will receive a single dose of PRX-101 (Dose A) administered under fasted conditions and 5 minutes prior to completing a cold pressor test. The cold pressor test is a test where the participant will be asked to hold their hand in an ice bath of cold water for up to 2 minutes.. All study drug will be given in the clinical research unit and adherence to the intervention will be through direct observation.
Intervention code [1] 331700 0
Treatment: Drugs
Comparator / control treatment
10mg intravenous verapamil hydrochloride
Control group
Active

Outcomes
Primary outcome [1] 342422 0
Safety of PRX-101 compared to intravenous verapamil hydrochloride will be assessed as a composite outcome through the assessment of: treatment-emergent adverse events, physical examination data, vital sign data including blood pressure, heart rate, temperature and respiratory rate, ECG data, oral cavity examination, taste survey and clinical laboratory assessments of blood and urine: hematology (standard panel), chemistry (standard panel) and urinalysis (standard panel)
Timepoint [1] 342422 0
Treatment-emergent adverse events will be collected from the time of signing the informed consent form through the final visit which is Day 16 post dose. Timepoints include screening, Day -1 to Day 9 while in the clinical unit and at the Day 16 post dose visit
Secondary outcome [1] 450735 0
Plasma concentrations of verapamil after a single oral dose of PRX-101 and after a single intravenous dose of verapamil hydrochloride
Timepoint [1] 450735 0
On Day 1, 3, 5 and 7 samples will be collected pre-dose and then at 2, 5, 10, 15, 25, 50 and 90 minutes and 6 and 12 hours post dose. On Day 2, 4, and 6 a 24-hour and 36-hour postdose sample will be collected. On Day 8 a 24 hour post Day 7 dose sample will be collected.
Secondary outcome [2] 450736 0
Effect of PRX-101 on cardiovascular reactivity assessed as a composite outcome of blood pressure, heart rate and respiratory rate
Timepoint [2] 450736 0
ECGs will be collected at screening, on Day -1, on Day 1, Day 3, Day 5 and Day 7 predose and at 5, 10, 15, 25 and 90 minutes and 6 hours post dose, on Day 8 predose and 5 minutes after removing the hand from the cold water bath, on Day 9 and on Day 16. Vital signs will be collected at screening, on Day -1, on Day 1, Day 3, Day 5 and Day 7 predose and 1.5, 3, 5, 7, 10, 15, 25, 50, and 90 minutes and 6- and 12-hours post dose, on Days 2, 4, and 6 at 24 hours post dose, on Day 8 predose, immediately before immersion, 15 seconds after immersion and every 30 seconds thereafter during immersion, immediately upon removal of the hand from the ice bath and every 30 seconds for 2 minutes after removal of the hand, on Day 9 and on Day 16.

Eligibility
Key inclusion criteria
1. Aged between 18 to 55 years of age (inclusive) at the time of signing the informed consent.
2. Deemed healthy as determined by medical history, physical examination, vital sign measurements, ECG, and laboratory safety tests performed at the Screening Visit and/or before the first dose of study drug.
3. Not lactating or pregnant as confirmed by a serum pregnancy test at Screening and negative urine pregnancy test before dosing (applies only to participants of child-bearing potential.
4. Has a blood pressure increase of 10-20mmHg on the cold pressor test (Part 2 only).
5. Body weight at least 50Kg (male) and 45Kg (female) and body mass index within the range 18-32 kg/m2 (inclusive) at Screening
6. Agrees to comply with contraceptive guidance
7. Capable of giving signed informed consent.
8. Negative severe acute respiratory syndrome SARS-CoV-2 (COVID-19) test prior to admission, if required per clinical research unit standards.
9. Smoke no more than 2 cigarettes, pipes, cigars, e-cigarettes, or equivalent per week, including nicotine products, from 3 months before Screening and is willing to abstain from smoking/using nicotine products during the confinement period.
10. Willing to refrain from over-the-counter or prescription medications or herbal, nutritional or dietary supplements from 14 days before first dose until the end of study assessments have been completed, except for oral contraceptives, hormone replacement therapy and limited use of paracetamol or in the case of necessary treatment of AEs.
11. Willing to refrain from alcohol and caffeine from 48 hours before the first dose through the last dose of study drug.
12. Agrees to be available for all study visits and cooperates fully with the requirements of the study protocol, including the schedule of assessments.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Past or current history of moderate or severe psychiatric illness based on the physician’s judgement and as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).
2. Past or current history of mild, moderate, or severe substance abuse according to DSM-5 definition within the previous 5 years before Screening.
3. Past or current history of alcohol use disorder defined as an average daily intake >3 units, or an average weekly intake >21 units, where 1 unit is equivalent to 1 can or bottle (355mL) of beer, or 1 measure (25mL) of spirits, or 1 glass (175 mL) of wine within 5 years prior to screening.
4. History of acute illness, infectious condition (e.g., COVID-19 or influenza) or chronic disease within 14 days before Screening or at Day -1, or current signs and symptoms of any diseases or conditions that would make participation not be in the best interest (eg, compromise the well-being) of the participant.
5. Any history of cardiovascular, cerebrovascular, or peripheral vascular disease.
6. Active malignancy, or history of malignancy, excluding basal or squamous cell carcinoma of the skin, within 2 years before Screening.
7. Any known allergy or hypersensitivity to verapamil or to any of the excipients in the formulation.
8. Use or intend to use any prescription medications/products within 14 days prior to check-in on Day -1, unless deemed acceptable by the Investigator (or designee).
9. Use or intend to use slow-release medications/products considered to still be active within 14 days before check-in on Day -1, unless deemed acceptable by the Investigator (or designee).
10. Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic-/herbal-/plant-derived preparations within 7 days before check-in on Day 1, unless deemed acceptable by the Investigator (or designee)
11. Received treatment with another investigational drug, investigational device, or approved therapy for investigational use within 30 days or 5 half-lives (whichever is longer) before Screening
12. Immunized with a live-attenuated vaccine within 30 days before Screening.
13. Prior exposure to PRX-101
14. Positive alcohol breath test or urine test for drugs of abuse at screening and at the time of admission
15. Positive serology panel.
16. Clinically significant vital sign measurements at Screening.
17. Clinically significant laboratory abnormalities
18. Clinically significant history or presence of ECG findings
19. Poor venous access.
20. Donated blood or plasma within 30 days before Screening, lost more than 500 mL of whole blood within the 30 days before Screening, or received a blood transfusion within 1 year before Screening.
21. From a vulnerable population as defined by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guideline for Good Clinical Practice (GCP) E6 (R2)

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated simple randomisation sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/11/2025
Actual
Date of last participant enrolment
Anticipated
1/04/2026
Actual
Date of last data collection
Anticipated
16/04/2026
Actual
Sample size
Target
38
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 28301 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 44513 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 319658 0
Commercial sector/Industry
Name [1] 319658 0
Phocus Pharmaceuticals, Inc.
Country [1] 319658 0
Canada
Primary sponsor type
Commercial sector/Industry
Name
Phocus Pharmaceuticals, Inc.
Address
Country
Canada
Secondary sponsor category [1] 322158 0
Commercial sector/Industry
Name [1] 322158 0
InClin Pty Ltd
Address [1] 322158 0
Country [1] 322158 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 318220 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 318220 0
Ethics committee country [1] 318220 0
Australia
Date submitted for ethics approval [1] 318220 0
04/08/2025
Approval date [1] 318220 0
Ethics approval number [1] 318220 0

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

Contacts
Principal investigator
Name 143478 0
Prof Guy Ludbrook
Address 143478 0
PARC Clinical Research, Royal Adelaide Hospital, Port Rd, Adelaide SA 5000
Country 143478 0
Australia
Phone 143478 0
+61413817901
Fax 143478 0
Email 143478 0
[email protected]
Contact person for public queries
Name 143479 0
Georgina Kilfoil
Address 143479 0
Phocus Pharmaceuticals 315 rue Strasbourg, Dollard-des-Ormeaux, Quebec, H9G1R9
Country 143479 0
Canada
Phone 143479 0
+61432388772
Fax 143479 0
Email 143479 0
[email protected]
Contact person for scientific queries
Name 143480 0
Georgina Kilfoil
Address 143480 0
Phocus Pharmaceuticals 315 rue Strasbourg, Dollard-des-Ormeaux, Quebec, H9G1R9
Country 143480 0
Canada
Phone 143480 0
+61432388772
Fax 143480 0
Email 143480 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Only aggregate participant data will be available from this study



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.