Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000464662
Ethics application status
Approved
Date submitted
30/03/2023
Date registered
5/05/2023
Date last updated
1/12/2023
Date data sharing statement initially provided
5/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Part C: A Study of SGR-1505 in Healthy Volunteer Participants
Scientific title
Part C: A 4-Part Dose-Escalation, Food Effect, And Drug-Drug Interaction Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of SGR-1505 In Healthy Volunteers
Secondary ID [1] 309344 0
SGR-1505-102
Universal Trial Number (UTN)
Trial acronym
Linked study record
This is a sub-study of the clinical trial which has been registered under ACTRN12623000358640.

Health condition
Health condition(s) or problem(s) studied:
Activated B-cell diff use large B-cell lymphoma (ABC-DLBCL) 329549 0
Condition category
Condition code
Cancer 326482 326482 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
SGR-1505 is an oral small molecule inhibitor of mucosa-associated lymphoid tissue lymphoma translocation protein 1 (MALT1) and is intended for the treatment of mature non-Hodgkin B-cell lymphomas, with the primary indication in activated B-cell diff use large B-cell lymphoma (ABC-DLBCL).
Investigational Product: SGR-1505
Dosage Formulation: Tablet
Route of Administration: Oral
Part C of this study will evaluate the food effect on the PK profile of SGR-1505, at 200 mg. Total of 12 participants will be assigned randomly into 1 of 2 sequences (6 participants per sequence). Both sequences will be conducted at the same time.
In sequence 1, 6 participants will receive single dose of 200 mg of SGR-1505 on Day 1 in fed state and Day 14 in the fasted state. In sequence 2, 6 participants will receive a single dose of SGR-1505 in the fasted state and Day 14 in the fed state.
Participants in the fed state will consume a standard high-fat, high-calorie breakfast following an overnight fast of at least 10 hours. Study participants will begin eating the recommended meal 30 minutes before administration of SGR-1505 and should consume this meal in 30 minutes or less. Afterwards, study participants will take SGR-1505 with 240 mL (8 fluid ounces) of water. No water allowed for 1 hour pre-dose and 1 hour post-dose. No food is allowed for at least 4 hours after the dose. The composition of the standardised meal provided to participants is 800- 1000 calories, 150 calories of protein, 250 calories of carbohydrates, 500- 600 calories of fat.
Participants in the fasted state will take SGR-1505 after an overnight fast of at least 10 hours. No water allowed for 1 hour pre- dose and 1 hour post-dose. No food is allowed for at least 4 hours after the dose.

Part C may commence once the Part A dose level (described in ACTRN12623000358640) has been deemed safe and tolerable.
The subjects are domiciled at the Phase 1 unit and dosing administered and verified by the staff for all parts of the study
Intervention code [1] 325782 0
Treatment: Drugs
Comparator / control treatment
The comparator group is the fasted state
Control group
Active

Outcomes
Primary outcome [1] 334321 0
To assess the safety and tolerability of SGR-1505 following single and repeat doses in healthy participants.
To be assessed by monitoring
- The Incidence and severity of adverse events (AEs). An assessment of AE severity will be performed according to the United States Food and Drug Administration (USFDA) Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
- Clinical laboratory findings (Clinical Chemistry, Hematology, Coagulation): blood sample collection and analysis by pathology lab
- 12-lead Electrocardiogram (ECG)
- Vital sign measurements of (systolic/diastolic blood pressure - pulse rate -; body temperature - and respiratory rate using standard manual or electronic clinical procedures.
Timepoint [1] 334321 0
Part C: Adverse events (AE) will be monitored once daily from baseline to Day 27 post-dose administration
Secondary outcome [1] 420247 0
Part C: To assess the effect of food on the PK of SGR-1505 in healthy participants.
Differences in PK parameters for SGR-1505 in the fed state relative to the fasted state, includes area under the plasma drug concentration versus time curve (AUC0-8), maximum observed plasma drug concentration (Cmax), and time to maximum observed plasma drug concentration (tmax)
Timepoint [1] 420247 0
Part C: Day 1: predose, 30 minutes post-dose, 1, 2, 4, 8, hours post dose. Then once daily Day 2-14. Day 14:30 minutes post-dose, 1, 2, 4, 8, hours post dose. Then once daily Day 15-27.

Eligibility
Key inclusion criteria
1. Male or female participant must be between 18 and 60 years of age (inclusive) at the time of signing the informed consent form (ICF).
2. Participant must understand and sign an ICF prior to any study-related assessments/procedures being conducted.
3. Body mass index (BMI) of 18.0 to 32.0 kg/m2 (inclusive) with a minimum body weight of 45 kg.
4. Participant must be able to comply with the study protocol and adhere to the study visit schedule in the Investigator’s judgment.
5. Participant must be in good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations at Screening and upon check-in as assessed by the Investigator (or designee), as applicable.
6. Women of childbearing potential must have a negative serum pregnancy test within 14 days of the first dose of study treatment (during screening), and a negative serum or urine pregnancy test within 24 hours of the first dose of study treatment.
7. Men and women of childbearing potential must agree to use highly effective contraception and refrain from egg or sperm donation throughout the study (from signing of the ICF and for 90 days after the last dose of study drug).
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Diseases or conditions known to interfere with absorption, distribution, metabolism, or excretion of drugs.
2. Use of any investigational drug within 30 days, or 5 half-lives, whichever is longer, prior to the planned first drug administration.
3. Participant with any clinically significant active symptoms at time of enrollment.
4. Participant has a known allergy to SGR-1505, components of SGR-1505, or an allergy to Posaconazole for participants considered for enrollment into the DDI cohort.
5. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements(including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inhibitor or inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication.
6. Participants with known history of Gilbert’s syndrome.
7. Participants with chronic jaundice and/or a known familial history of jaundice.
8. Participants who are pregnant, breastfeeding or intending to become pregnant during the study or within 90 days after the last dose of study treatment.
9. Participant has any condition, including clinically significant acute bacterial, viral, or fungal infection which places the participant at unacceptable risk if he/she were to participate in the study.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/08/2023
Actual
25/08/2023
Date of last participant enrolment
Anticipated
31/10/2023
Actual
25/08/2023
Date of last data collection
Anticipated
30/11/2023
Actual
27/09/2023
Sample size
Target
12
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24440 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 40021 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 313545 0
Commercial sector/Industry
Name [1] 313545 0
Schrödinger, Inc.
Country [1] 313545 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Schrödinger, Inc.
Address
1540 Broadway, 24th Floor New York, NY 10036
Country
United States of America
Secondary sponsor category [1] 315322 0
None
Name [1] 315322 0
Address [1] 315322 0
Country [1] 315322 0
Other collaborator category [1] 282603 0
Commercial sector/Industry
Name [1] 282603 0
Novotech (Australia) Pty Limited
Address [1] 282603 0
Level 3, 235 Pyrmont Street Sydney, NSW Australia - 2009
Country [1] 282603 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312727 0
The Alfred Hospital Ethics Committee HREC
Ethics committee address [1] 312727 0
Ethics committee country [1] 312727 0
Australia
Date submitted for ethics approval [1] 312727 0
23/01/2023
Approval date [1] 312727 0
03/03/2023
Ethics approval number [1] 312727 0

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

Contacts
Principal investigator
Name 125690 0
Dr Jason Lickliter
Address 125690 0
Nucleus Network,
Level 5 Burnet Tower,
89 Commercial Road, Melbourne,
Victoria 3004
Country 125690 0
Australia
Phone 125690 0
+61 390768960
Fax 125690 0
Email 125690 0
[email protected]
Contact person for public queries
Name 125691 0
Daniel Weiss
Address 125691 0
Schrödinger, Inc.,
1540 Broadway, 21st Floor, New York City, New York, 10036
Country 125691 0
United States of America
Phone 125691 0
+15032991150
Fax 125691 0
Email 125691 0
[email protected]
Contact person for scientific queries
Name 125692 0
Daniel Weiss
Address 125692 0
Schrödinger, Inc.,
1540 Broadway, 21st Floor, New York City, New York, 10036
Country 125692 0
United States of America
Phone 125692 0
+15032991150
Fax 125692 0
Email 125692 0
[email protected]

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


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.