Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001348741
Ethics application status
Approved
Date submitted
5/10/2022
Date registered
20/10/2022
Date last updated
30/05/2023
Date data sharing statement initially provided
20/10/2022
Date results information initially provided
30/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 1 Study of MAXONA Pharmaceuticals MAX-001 healthy subjects for the selection of an extended release form based on the evaluation of safety, tolerability, and drug concentrations
Scientific title
Phase 1 Integrated Randomized Open-Label Formulation Selection and Food Effect Assessment Study of MAX-001 in Healthy Subjects
Secondary ID [1] 308090 0
MAXONA Pharmaceuticals Study MAX-001-101 Stage 1
Universal Trial Number (UTN)
U1111-1283-4547
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Various pain indications 327783 0
Condition category
Condition code
Anaesthesiology 324852 324852 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
MAX-001-101 Stage 1 is part of a two-part study within which parts 1 (formulation selection) and 2 (food effect assessment) will be conducted sequentially. Each study part will involve unique participants.

Part 1: Formulation Selection
Using a cross over design, a total of 14 participants will each receive a single oral administration of each of 3 different formulations of MAX-001 and single oral administration of the reference formulation. Administered doses of each of the 4 formulations will be 30mg MAX-001 ER1, 30mg MAX-001 ER2, 30mg MAX-001 ER3, and 30mg IR. The wash-out period between each single dose administration is 1 week. Healthy volunteers will stay in the clinical research unit for the entire duration of dosing and will take study drug under direct supervision of the clinical research unit staff.

Part 2: Food Effect
A total of 20 participants will be enrolled across two cohorts to each receive a single oral administration of two formulations selected from Part 1 with and without food. The wash-out period between each single dose administration is 1 week. Each oral administration is to occur either after a 10 hour overnight fast or 30 minutes after the ingestion of a high calorie and high-fat breakfast. The standardised meal will be the standard US Food and Drug Administration high-fat, high calorie (800 to 1000 calories) breakfast. Healthy volunteers will stay in the clinical research unit for the entire duration of dosing and will take study drug under direct supervision of the clinical research unit staff.
Intervention code [1] 324539 0
Treatment: Drugs
Comparator / control treatment
4 formulations will be compared: 30mg MAX-001 extended formulation 1, 30mg MAX-001 extended formulation 2, 30mg MAX-001 extended formulation 3, and 30mg generic nefopam immediate release
Control group
Dose comparison

Outcomes
Primary outcome [1] 332669 0
Safety and tolerability will be assessed by clinical monitoring and will assess change from baseline for physical exams, vital signs, hematology, chemistry and urinalysis labs, 12-lead electrocardiograms (ECGs), and adverse events reporting. Adverse events will be reported by the participant. The Investigator and any designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. Events meeting the AE definition include: • Any abnormal laboratory test results (hematology, coagulation, clinical chemistry, or urinalysis) or other safety assessments (eg, ECG, vital signs measurements, or physical examinations), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator. • Exacerbation of a chronic or intermittent pre-existing condition including either an increase in frequency and/or intensity of the condition. • New conditions detected or diagnosed after study drug administration although it may have been present before the start of the study. • Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction. • Signs, symptoms, or the clinical sequelae of a suspected overdose of either study drug or a concomitant medication. Overdose per se will not be reported as an AE/SAE unless it is an intentional overdose taken with possible suicidal/self-harming intent. Such overdoses should be reported regardless of sequelae. Severity categories of AE assessment include mild, moderate, and severe, as defined below- • Mild: A type of adverse event that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living • Moderate: A type of adverse event that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the research subject. • Severe: A type of adverse event that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Vital signs measurements will include tympanic body temperature, pulse rate, and blood pressure. Blood pressure and pulse rate will be assessed with a completely automated device; manual techniques will be used only if an automated device is not available.
Timepoint [1] 332669 0
Clinical laboratory blood tests will be assessed at Screening and on Day -1, Day 1, Day 2, and Day 3 for each dose. Clinical laboratory urinalysis will be assessed at Screening and on Day -1, Day 2, and Day 3. A complete physical examination will be assessed at screening, while symptom-directed physical examinations will be assessed on Day -1, Day 1, Day 2 and Day 3. Vital signs will be assessed at Screening and on Day -1, Day 1, Day 2 and Day 3 . 12-Lead ECG will be assessed at Screening and on Day -1, Day 1, Day 2 and Day 3. AEs/SAEs will be assessed at all timepoints.
Primary outcome [2] 332670 0
Pharmacokinetic (PK) profile: Cmax, Cmin, AUCinf, AUClast, Tmax, Tmin, and t ½
Timepoint [2] 332670 0
pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, and 48 hours after each dose.
Secondary outcome [1] 414599 0
Nil
Timepoint [1] 414599 0
Nil

Eligibility
Key inclusion criteria
- Able to understand, sign, and commit to informed consent and to all study procedures
- Adhere to effective double-barrier contraception or in proven post-menopause
- Healthy as determined during screening based on medical history, physical examination, vital signs, ECG (QTcF <=450 msec in males, QTcF <=470 in females), and laboratory assessments
- Body Mass Index 18 to 32.0 kg/m2
- Non-smokers or social smokers (0-5 cigarettes per month)
- Commitment to adhere to lifestyle guidance during the study participation
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Any lifetime antecedent, any disease or medication indicative of past seizures, epilepsy, or any disease or medication that increases the risk of seizures
- Any antecedent of ischemic heart disease, angina, QTcF > 450 msec in males and > 470 msec in females, QRS prolongation, arrhythmia, and prior occurrence of torsades de pointe, as well as absence of family history of long QT syndrome or sudden cardiac death
- Any antidepressant use, such as a monoamine oxidase inhibitor like phenelzine, a tricyclic antidepressant such as amitriptyline or nortryptiline, or a single-, double-, or triple monoamine reuptake inhibitor (SSRI, SNRI, SNDRI)
- Use of drowsiness-causing antihistaminics
- Serology indicative of HIV or hepatitis B or C
- Abnormal liver function tests
- Abnormal renal function tests as assessed by the creatinine clearance
- Past or current cancer and its treatment
- Glaucoma
- Substance use disorder in medical history, urine drug screen and alcohol breath test
- Mental health disorder diagnosis and/or treatment
- Pregnancy or breastfeeding

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)
Simple randomization using a randomization table created by computer software (i.e. computerized sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Crossover
Other design features
Randomized open-label crossover design for both the formulation selection and food effect assessment parts
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis
Listings and tabulation of safety and tolerability variables
Pharmacokinetic analysis and modeling to estimate and visualize standard parameters
Sample size is based on customary practice in Phase 1 clinical studies

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/11/2022
Actual
28/11/2022
Date of last participant enrolment
Anticipated
8/06/2023
Actual
30/01/2023
Date of last data collection
Anticipated
25/06/2023
Actual
24/02/2023
Sample size
Target
34
Accrual to date
Final
34
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23276 0
Nucleus Network - Melbourne
Recruitment hospital [2] 24815 0
Nucleus Network - Geelong
Recruitment postcode(s) [1] 38646 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 312347 0
Commercial sector/Industry
Name [1] 312347 0
MAXONA Australia Pty, Ltd
Country [1] 312347 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
George Clinical Pty Ltd
Address
Level 5, 1 King Street,
Newtown, NSW 2042
Country
Australia
Secondary sponsor category [1] 313910 0
None
Name [1] 313910 0
Address [1] 313910 0
Country [1] 313910 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311710 0
Alfred Health Ethics Committee
Ethics committee address [1] 311710 0
55 Commercial Rd,
Melbourne VIC 3004
Ethics committee country [1] 311710 0
Australia
Date submitted for ethics approval [1] 311710 0
04/10/2022
Approval date [1] 311710 0
02/11/2022
Ethics approval number [1] 311710 0

Summary
Brief summary
A Phase 1 clinical study in healthy subjects to evaluate the extended-release formulation candidates and assess their associated food effect to select the optimal extended release formulation based on the safety, tolerability, and plasma drug concentration profile of MAXONA Pharmaceuticals MAX-001
Trial website
Trial related presentations / publications
Public notes
Exclusion criteria:
- Febrile illness or COVID-19 symptoms within 28 days prior to screening
- Positive PCR test for COVID-19 within 1 month prior to screening or at CRU admission and no exposure to contact(s) with clinical COVID-19 symptoms within the last 14 days
- COVID-19 vaccination within 30 days prior to study drug administration

The lifestyle guidelines applicable to participants in this study are captured in the Participant Information Sheet and Informed Consent (PICF) and will be explained during the consenting process. As specified within the PICF, participants will be requested to abstain from certain foods, alcohol, tobacco products, and unaccustomed exercise prior to and during admission to the clinical research unit.

Contacts
Principal investigator
Name 122086 0
Dr Sam Francis
Address 122086 0
Nucleus Network Pty Ltd
Level 1,
484 St Kilda Road,
Melbourne VIC 3004
Country 122086 0
Australia
Phone 122086 0
+61 481 843 422
Fax 122086 0
Email 122086 0
s.francis@nucleusnetwork.com.au
Contact person for public queries
Name 122087 0
Dr Sam Francis
Address 122087 0
Nucleus Network Pty Ltd
Level 1,
484 St Kilda Road,
Melbourne VIC 3004
Country 122087 0
Australia
Phone 122087 0
+61 481 843 422
Fax 122087 0
Email 122087 0
s.francis@nucleusnetwork.com.au
Contact person for scientific queries
Name 122088 0
Dr Sam Francis
Address 122088 0
Nucleus Network Pty Ltd
Level 1,
484 St Kilda Road,
Melbourne VIC 3004
Country 122088 0
Australia
Phone 122088 0
+61 481 843 422
Fax 122088 0
Email 122088 0
s.francis@nucleusnetwork.com.au

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


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.