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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05857384




Registration number
NCT05857384
Ethics application status
Date submitted
27/02/2023
Date registered
12/05/2023
Date last updated
6/05/2024

Titles & IDs
Public title
Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs
Scientific title
A Randomised Four-Period Cross-Over Phase I Study to Assess Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs in Healthy Volunteers
Secondary ID [1] 0 0
IHL42XBABE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - IHL42X
Treatment: Drugs - Acetazolamide 250 MG
Treatment: Drugs - Dronabinol 2.5 MG

Active Comparator: Comparator Arm A- Reference Listed Drug/Marinol - dronabinol 5 mg, two capsules of 2.5 mg administered on an empty stomach once only in the study period

Active Comparator: Comparator Arm B-Reference Listed Drug/Taro Acetazolamide - 250 mg acetazolamide, one tablet administered on an empty stomach once only in the study period

Experimental: Investigational Product Arm C-IHL42X Fasted - IHL-42X (5 mg dronabinol, 250 mg acetazolamide), one capsule administered on an empty stomach once only in the study period

Experimental: Investigational Product Arm D-IHL42X Fed - IHL-42X (5 mg dronabinol, 250 mg acetazolamide), one capsule administered after food once only in the study period


Treatment: Drugs: IHL42X
IHL-42X consists of acetazolamide and dronabinol.

Treatment: Drugs: Acetazolamide 250 MG
A solid tablet containing 250 mg acetazolamide

Treatment: Drugs: Dronabinol 2.5 MG
A soft gelatin capsules containing 2.5mg dronabinol
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Bioavailability of IHL-42X
Timepoint [1] 0 0
28 days
Primary outcome [2] 0 0
Bioequivalence of IHL-42X
Timepoint [2] 0 0
28 days
Primary outcome [3] 0 0
Effect of food on IHL-42X - maximum observed drug concentration
Timepoint [3] 0 0
7 days
Primary outcome [4] 0 0
Effect of food on IHL-42X - time of the maximum drug concentration
Timepoint [4] 0 0
7 days
Primary outcome [5] 0 0
Effect of food on IHL-42X - area under the drug concentration time curve from time zero to time of last measurable concentration
Timepoint [5] 0 0
7 days
Primary outcome [6] 0 0
Effect of food on IHL-42X - area under the drug concentration time curve from time zero to infinity
Timepoint [6] 0 0
7 days
Primary outcome [7] 0 0
Effect of food on IHL-42X - area under the drug concentration time curve from time zero to 12 hours
Timepoint [7] 0 0
7 days
Primary outcome [8] 0 0
Effect of food on IHL-42X - area under the drug concentration time curve from time zero to 24 hours
Timepoint [8] 0 0
7 days
Primary outcome [9] 0 0
Effect of food on IHL-42X - the elimination half-life
Timepoint [9] 0 0
7 days
Primary outcome [10] 0 0
Effect of food on IHL-42X - terminal elimination rate constant
Timepoint [10] 0 0
7 days
Primary outcome [11] 0 0
Effect of food on IHL-42X - apparent total body clearance
Timepoint [11] 0 0
7 days
Primary outcome [12] 0 0
Effect of food on IHL-42X - apparent volume of distribution
Timepoint [12] 0 0
7 days
Secondary outcome [1] 0 0
Safety and tolerability
Timepoint [1] 0 0
28 days

Eligibility
Key inclusion criteria
- Healthy volunteers will be enrolled in the study if they satisfy all the following
criteria:

1. Ages =18 to =65 at the time of screening

2. BMI =18.0 to =32.0

3. Physically well, in the opinion of the investigator, with no clinically
significant psychiatric, cardiac, hepatic, renal, endocrine, gastrointestinal,
bleeding, thyroid, cholesterol, or hypertension disorders

4. If male, willing to use an approved method of contraception from 30 days prior to
dosing, throughout the study, and 90 days after last dose.

Options include:

Surgically sterile (vasectomy at least 6 months prior to dosing) Condom + partner
with IUD device (in place 3 months prior to dosing through to 90 days after last
dose) Condom + partner with diaphragm for at least 30 days prior to dosing
through to 90 days after last dose Condom + partner using hormonal contraception
for at least 3 months prior to dosing + condom for at least 30 days prior to
dosing through to 90 days after last dose OR Contraception not required Sexual
partner is surgically sterile. Partner is of non-childbearing potential Same sex
relationship Abstinence

5. If female of non-childbearing potential, must be postmenopausal with established
serum FSH levels >30IU/L (determined during screening or have undergone one of
the following sterilization procedures at least 6 months prior to Visit Day 1;

1. Bilateral tubal ligation

2. Hysterectomy

3. Hysterectomy with unilateral or bilateral oophorectomy

4. Bilateral oophorectomy If females of childbearing potential must not be
currently pregnant, lactating, or planning to be pregnant and are willing to
use an approved method of contraception from 30 days prior to dosing,
throughout the study, and 30 days after last dose.

Options include:

Condom + IUD device (in place 3 months prior to dosing + 30 days after last dose)
Condom + Diaphragm for at least 30 days prior to dosing + 30 days after last dose
Condom + Hormonal contraception for at least 3 months prior to dosing + condom
for at least 30 days prior to dosing + 30 days after last dose OR Contraception
not required Partner has had a vasectomy at least 6 months prior to first dose Of
non-childbearing potential (postmenopausal or surgically sterile by any method
for at least 3 months prior to check-in) Abstinence Same sex relationship

6. Voluntarily consent to participate in the study and complete all study required
tasks, as instructed by the protocol, including the completion of questionnaires.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Healthy volunteers will be excluded from the study if there is evidence of any of the
following at screening, or prior to dosing at the timepoints in the Schedule of
Events.

1. History of cardiac disease or arrythmias

2. History of significant psychiatric illness (defined as hospitalisation or history
of pharmacological prescription for psychiatric conditions), suicidal ideation,
or suicidal attempts

3. Current use of illicit drugs or as defined by a positive urine drug test at
screening or baseline

4. History of alcohol abuse or excessive alcohol intake according to the Australian
guidelines (more than 10 standard drinks per week/4 standard drinks per day on
average) or alcohol consumption (by self-declaration) defined as > 21 alcohol
units per week (where 1 unit = 284 mL of beer, 25 mL of 40% spirit, or a 125 mL
glass of wine).

5. Any cannabis use within 30 days of screening

6. Known hypersensitivity and/or intolerance to any cannabis products with previous
use

7. Known hypersensitivity and/or intolerance to sesame oil (dronabinol is formulated
in sesame oil)

8. Known hypersensitivity and/or intolerance to acetazolamide

9. Has taken any vitamins, herbal remedies, supplements or cannabidiol products
within 7 days of each check-in

10. GAD-7 score of =15, MDI score =31 OR 3 core symptoms and 5 accompanying symptoms,
C-SSRS score =4 OR reported suicidal behaviour within the past 3 months

11. Any dietary requirements incompatible with study breakfast; must be able to eat
high-fat, high-calorie diet (including meat, dairy products) (As described in FDA
guidance for BA and BE studies (Appendix 6))

12. Hepatic or renal impairment or disease, as defined as AST/ALT >1.5 x ULN, eGFR
<60 at screening and check-in.

13. History of gastrointestinal disorders or previous surgeries which may impact
absorption, distribution, metabolism and/or excretion of the IP (such as
cholecystitis, cholecystectomy)

14. Female participants who are pregnant, lactating or planning to become pregnant

15. Inability to adhere to the protocol and study restrictions during the study
period

16. Participation in another clinical trial of an investigational drug within 30 days
or 5 half-lives of the investigational drug (whichever is longer) prior to first
study drug administration.

17. Any other reason in the opinion of the investigator

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
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/09/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2024
Actual
Sample size
Target
116
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
CMAX - Adelaide
Recruitment hospital [2] 0 0
Nucleus Network Pty Ltd - Geelong
Recruitment hospital [3] 0 0
Nucleus Network Pty Ltd [Commercial Road] - Melbourne
Recruitment hospital [4] 0 0
Nucleus Network Pty Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3220 - Geelong
Recruitment postcode(s) [3] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Incannex Healthcare Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The goal of this randomised four-period cross-over Phase I study is to assess
bioavailability, bioequivalence and tolerability of IHL-42X compared to the reference drugs
in healthy volunteers.

Volunteers will be enrolled and randomised to one of four treatment groups. Each group is to
receive all four treatments in a twenty eight day cross-over study, with each treatment
period running for seven days.

The four treatment groups are described below; A = dronabinol 5 mg, fasted; B = acetazolamide
250 mg, fasted; C = IHL-42X (5 mg dronabinol, 250 mg acetazolamide), fasted; D = IHL-42X (5
mg dronabinol, 250 mg acetazolamide), fed. Each treatment group will enrol at least 29
participants each, for a total of at least 116 participants.

Bioavailability and bioequivalence will assess and compare all four of the seven day
treatments.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05857384
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Emir Redzepagic, MBBS
Address 0 0
CMAX Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Mark Bleackley, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 (0) 400 423 364
Fax 0 0
Email 0 0
mark@incannex.com.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05857384