None listed
Conditions
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
Interventions
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
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.
Sponsors
George Clinical Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
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
Outcome results
None listed