Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000662460
Ethics application status
Approved
Date submitted
14/05/2025
Date registered
23/06/2025
Date last updated
23/06/2025
Date data sharing statement initially provided
23/06/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
A trial with healthy adult volunteers testing the effect of food on what happens to the drug emestedastat in the body
Scientific title
A Randomized, Open-label, Single Dose, Crossover Trial to Assess the Effects of Food on the Pharmacokinetics of 10 mg Emestedastat Tablet in Healthy Adult Participants
Secondary ID [1] 314443 0
ACW0011
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 337476 0
Major depressive disorder 337477 0
Condition category
Condition code
Mental Health 333845 333845 0 0
Depression
Neurological 333844 333844 0 0
Alzheimer's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
emestedastat 10 mg oral tablet, 2 single doses, with a washout period of one week between treatments. Doses will be taken in either the fasted or fed state, both states are under assessment.
Doses will be taken under supervision and will be checked by a second member of staff. A hand and mouth check will be conducted after each participant has been dosed.
The fed state involves consumption of a high fat and high calorie meal during a 30-minute period that commences 45 minutes prior to dosing. It should derive approximately 150, 250, and 500 to 600 calories from protein, carbohydrate, and fat, respectively, as defined in regulatory guidance.
The fasted state involves a 10-hour overnight fast.
Intervention code [1] 331065 0
Treatment: Drugs
Comparator / control treatment
Participants will receive IP in the fasted state in one treatment arm (reference comparator). The fasted state involves a 10-hour overnight fast with water permitted at all times, apart from 1 hour before and 1 hour after dosing.
Control group
Active

Outcomes
Primary outcome [1] 341463 0
Single dose pharmacokinetics of emestedastat 10 mg in fed and fasted states: AUC, Cmax, Tmax, CL/F, Vz/F, and t1/2
Timepoint [1] 341463 0
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48 hours postdose.
Secondary outcome [1] 447582 0
Safety and tolerability (composite outcome)
Timepoint [1] 447582 0
up to 3 days post second dose

Eligibility
Key inclusion criteria
Participants in good general health
BMI between 18 and 32, inclusive
Non-smoker, able to abstain from caffeine/hot beverage intake prior to dosing
No relevant dietary restrictions and able to consume the non-vegetarian, high-fat meal provided
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality
Abnormalities in vital signs, ECG abnormalities
Use of any prescription drugs, over the counter medication, herbal remedies, supplements or vitamins, apart from simple analgesia
Unwilling to refrain from strenuous exercise during the trial
Not breastfeeding, lactating or planning pregnancy
History of drug or alcohol abuse

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised 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
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
16/06/2025
Date of last participant enrolment
Anticipated
24/06/2025
Actual
Date of last data collection
Anticipated
3/07/2025
Actual
Sample size
Target
16
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 318977 0
Commercial sector/Industry
Name [1] 318977 0
Actinogen Medical Ltd
Country [1] 318977 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Actinogen Medical Ltd
Address
Country
Australia
Secondary sponsor category [1] 321444 0
None
Name [1] 321444 0
Address [1] 321444 0
Country [1] 321444 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317582 0
Bellberry Human Research Ethics Committee G
Ethics committee address [1] 317582 0
Ethics committee country [1] 317582 0
Australia
Date submitted for ethics approval [1] 317582 0
07/05/2025
Approval date [1] 317582 0
13/05/2025
Ethics approval number [1] 317582 0

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

Contacts
Principal investigator
Name 141494 0
Dr Mohamed Bakra
Address 141494 0
CMAX, Ground Floor, 21-24 North Terrace, Adelaide SA 5000
Country 141494 0
Australia
Phone 141494 0
+61 0431 739 345
Fax 141494 0
Email 141494 0
[email protected]
Contact person for public queries
Name 141495 0
Natasha Masand
Address 141495 0
Actinogen Medical Ltd, Suite 901, Level 9, 109 Pitt St Sydney NSW 2000
Country 141495 0
Australia
Phone 141495 0
+61 02 8964 7401
Fax 141495 0
Email 141495 0
[email protected]
Contact person for scientific queries
Name 141496 0
Natasha Masand
Address 141496 0
Actinogen Medical Ltd, Suite 901, Level 9, 109 Pitt St Sydney NSW 2000
Country 141496 0
Australia
Phone 141496 0
+61 02 8964 7401
Fax 141496 0
Email 141496 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.