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Trial registered on ANZCTR


Registration number
ACTRN12624000031561
Ethics application status
Approved
Date submitted
5/12/2023
Date registered
15/01/2024
Date last updated
15/01/2024
Date data sharing statement initially provided
15/01/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Phase 1b, Single-centre, Open-label Study to Evaluate Food Effect and the Drug-Drug Interaction of Omeprazole, Itraconazole and Rifampin on Tinlarebant in Healthy Adult Subjects
Scientific title
A Phase 1b, Single-centre, Open-label Study to Evaluate Food Effect and the Drug-Drug Interaction of Omeprazole, Itraconazole and Rifampin on Tinlarebant in Healthy Adult Subjects
Secondary ID [1] 311111 0
LBS-008-CT09
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Geographic Atrophy 332267 0
Condition category
Condition code
Eye 328982 328982 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will be conducted in four independent Parts as follow:

Part 1(Tinlarebant+Omeprazole): 12 participants will take tinlarebant (5 mg) on Day 1 and Day 22, and take Omeprazole(40 mg) once daily on each Day 18-26.

Part 2 (Tinlarebant+Itraconazole): 12 participants will take tinlarebant (5 mg) on Day 1 and Day 22, and take Itraconazole (200 mg) twice daily on each Day 17-26.

Part 3 (Tinlarebant+Rifampin): 12 participants will take tinlarebant (5 mg) on Day 1 and Day 22, and take Rifampin (600 mg) once daily on each Day 14-26.

Part 4 (Food Effect): 12 participants will be randomized into two treatment sequences:
Sequence 1: to take tinlarebant (5mg) on Day 1 under fasted condition, and Day 22 under fed condition.
Sequence 2: to take tinlarebant (5mg) on Day 1 under fed condition, and Day 22 under fasted condition.
- Fasted condition: minimum 10 hour fast, water allowed until 1 hour before study drug administration.
- Fed condition: participants will have a standard high fat, high calorie meal includes: 2 eggs fried in butter, 2 rashers of bacon, 2 slices of toast with 16 g butter per slice, 125 g of hash browns and 240 mL of full cream milk.

All the study drug all be administrated orally, and recorded in dosing diaries at home or Electronic Medical Record on site.
Intervention code [1] 327562 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336775 0
To evaluate and compare the pharmacokinetic (PK) profile of tinlarebant after single dose administration with and without multiple doses of omeprazole (proton pump inhibitor [PPI])
Timepoint [1] 336775 0
Blood samples will be collected at 0, 0.5, 1, 2, 4, 6, 8, 12, 24 hours and days 3, 4, 6, 8 and 13 post-first dose; at 0, 0.5, 1, 2, 4, 6, 8, 12, 24 hours and days 3, 4, 6, 8 and 13 post-second dose on Day 22.
Primary outcome [2] 336776 0
To evaluate and compare the pharmacokinetic (PK) profile of tinlarebant after single dose administration with and without multiple doses of itraconazole (cytochrome P450 [CYP]3A4 inhibitor)
Timepoint [2] 336776 0
Blood samples will be collected at 0, 0.5, 1, 2, 4, 6, 8, 12, 24 hours and days 3, 4, 6, 8 and 13 post-first dose; at 0, 0.5, 1, 2, 4, 6, 8, 12, 24 hours and days 3, 4, 6, 8 and 13 post-second dose on Day 22.
Primary outcome [3] 336932 0
To evaluate and compare the pharmacokinetic (PK) profile of tinlarebant after single dose administration with and without multiple doses of rifampin (CYP3A4 inducer)
Timepoint [3] 336932 0
Blood samples will be collected at 0, 0.5, 1, 2, 4, 6, 8, 12, 24 hours and days 3, 4, 6, 8 and 13 post-first dose; at 0, 0.5, 1, 2, 4, 6, 8, 12, 24 hours and days 3, 4, 6, 8 and 13 post-second dose on Day 22.
Secondary outcome [1] 429654 0
Primary Outcome [4]
To determine the effect of a high calorie high fat meal on the PK profile of tinlarebant
Timepoint [1] 429654 0
Blood samples will be collected at 0, 0.5, 1, 2, 4, 6, 8, 12, 24 hours and days 3, 4, 6, 8 and 13 post-first dose; at 0, 0.5, 1, 2, 4, 6, 8, 12, 24 hours and days 3, 4, 6, 8 and 13 post-second dose on Day 22.
Secondary outcome [2] 430194 0
To investigate the safety and tolerability of tinlarebant, Safety endpoints include:
• Incidence, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs) (including withdrawals due to AEs).
• Change from baseline in vital sign measurements (systolic and diastolic blood pressure (BP), heart rate (HR), respiratory rate, and body temperature).
• Change from baseline in electrocardiogram (ECG) parameters.
• Change from baseline in clinical laboratory parameters (haematology, coagulation, serum chemistry, and urinalysis).
Timepoint [2] 430194 0
Full physical examination will be performed at screening visit and be symptom-directed on day -1, 18, 22, 36 post-first dose.

Vital signs assessment and 12-lead ECG will be performed at the screening visit, day -1, 1, 2, 18, 22, 23 and 36 (end of study visit).

Clinical laboratory tests will be conducted at the screening visit, day -1, 2, 18, 21, 23 and 36 (end of study visit).

Adverse events will be monitored daily from baseline to day 36 post-first dose.

Eligibility
Key inclusion criteria
Healthy male or female, aged between 18 to 65 years of age, inclusive, at screening.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of any clinically significant disorder, including cardiovascular (including unstable angina, myocardial infarction, chronic heart failure), haematologic, pulmonary, hepatic, renal, gastrointestinal, connective tissue disease, uncontrolled endocrine/metabolic, oncologic (within the last 5 years), neurologic (including seizures, strokes, brain tumours), and psychiatric diseases, or any disorder that the PI (or delegate) considers may prevent the successful completion of the study or influence the absorption, distribution, metabolism, excretion, or action of the study drug.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
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
7/01/2024
Date of last participant enrolment
Anticipated
27/02/2024
Actual
Date of last data collection
Anticipated
3/04/2024
Actual
Sample size
Target
48
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 25913 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment postcode(s) [1] 41747 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 315369 0
Commercial sector/Industry
Name [1] 315369 0
RBP4 Pty Ltd
Country [1] 315369 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
RBP4 Pty Ltd
Address
Level 7, 330 Collins Street Melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 317432 0
None
Name [1] 317432 0
Address [1] 317432 0
Country [1] 317432 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314286 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 314286 0
123 Glen Osmond Road Eastwood South Australia 5063
Ethics committee country [1] 314286 0
Australia
Date submitted for ethics approval [1] 314286 0
25/10/2023
Approval date [1] 314286 0
29/11/2023
Ethics approval number [1] 314286 0

Summary
Brief summary
This is an open-label study to evaluate the effect of food and drug-drug interaction with tinlarebant. This study will assess the effect of omeprazole, itraconazole,rifampin and food on the pharmacokinetics of tinlarebant.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131062 0
Dr Thomas Polasek
Address 131062 0
CMAX Clinical Research Pty Ltd. Level 5, 18a North Terrace, Adelaide, SA 5000
Country 131062 0
Australia
Phone 131062 0
+61 458162715
Fax 131062 0
Email 131062 0
thomas.polasek@cmax.com.au
Contact person for public queries
Name 131063 0
Ms Ciao Hong
Address 131063 0
Belite Bio. 36F, No. 68, Sec. 5, Zhongxiao East Rd., Xinyi Dist., Taipei City 11065, Taiwan
Country 131063 0
Taiwan, Province Of China
Phone 131063 0
+886227255355
Fax 131063 0
Email 131063 0
ciaohong@belitebio.com
Contact person for scientific queries
Name 131064 0
Dr Thomas Polasek
Address 131064 0
CMAX Clinical Research Pty Ltd. Level 5, 18a North Terrace, Adelaide, SA 5000
Country 131064 0
Australia
Phone 131064 0
+61 458162715
Fax 131064 0
Email 131064 0
thomas.polasek@cmax.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
At this time there is no plan to submit IPD, however, should this change, this record will be updatedaccordingly


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.