Part C: A Study of SGR-1505 in Healthy Volunteer Participants
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
Schrödinger, Inc.
12 participants
Aug 25, 2023
Interventional
Conditions
Summary
This study aims to assess the safety, tolerability and pharmacokinetics of a new cancer treatment, SGR-1505 that may be used for non-Hodgkin's lymphoma patients. Part C will evaluate the effect of food (FE) on the PK profile of SGR-1505 (provisionally at 200 mg, although the dose of SGR-1505 will be determined based on emerging PK data). Who is it for? You may be eligible for this study if you are a healthy adult aged between 18 and 60 years old. Please note that this study will not be enrolling patients with non-Hodgkin's lymphoma. Study details Part C will consist of 3 phases: a Screening phase (within 28 days of the first dose of SGR1505), a Treatment phase, and a Follow-up phase. The Follow-up visit will evaluate safety prior to initiating the subsequent cohorts and will occur on Day 34 (± 2 days). It is hoped this research will determine the safest dose of SGR-1505 that can be administered with non-Hodgkin's lymphoma
Eligibility
Inclusion Criteria7
- Male or female participant must be between 18 and 60 years of age (inclusive) at the time of signing the informed consent form (ICF).
- Participant must understand and sign an ICF prior to any study-related assessments/procedures being conducted.
- Body mass index (BMI) of 18.0 to 32.0 kg/m2 (inclusive) with a minimum body weight of 45 kg.
- Participant must be able to comply with the study protocol and adhere to the study visit schedule in the Investigator’s judgment.
- 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.
- 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.
- 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).
Exclusion Criteria9
- Diseases or conditions known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Use of any investigational drug within 30 days, or 5 half-lives, whichever is longer, prior to the planned first drug administration.
- Participant with any clinically significant active symptoms at time of enrollment.
- 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.
- 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.
- Participants with known history of Gilbert’s syndrome.
- Participants with chronic jaundice and/or a known familial history of jaundice.
- Participants who are pregnant, breastfeeding or intending to become pregnant during the study or within 90 days after the last dose of study treatment.
- 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.
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Interventions
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
Locations(1)
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ACTRN12623000464662