Part A, B and D: A Study of SGR-1505 in Healthy Volunteer Participants
Part A, B and D: 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
66 participants
Apr 17, 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. The study will consist of multiple parts that will assess administration of SGR-1505 alone and in combination with another treatment, posaconazole. 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 The first sub-study will enrol participants and test single doses of SGR-1505. If a certain dose is found to be safe, a new group of participants will be enrolled to test a higher single dose of SGR-1505. The second sub-study will enrol participants and test multiple doses of SGR-1505 over a 10-day period. If a certain dose is found to be safe, a new group of participants will be enrolled to test a higher dose of SGR-1505 over a 10-day period. 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 diffuse large B-cell lymphoma (ABC-DLBCL). Investigational Product: SGR-1505 Dosage Formulation: Tablet Route of Administration: Oral Study consists of 3 parts: Part A: study will evaluate the safety, tolerability, and PK of single ascending oral doses (SAD) of SGR-1505. Participants will enroll into each of the 6 SAD cohorts sequentially. All participants in the cohort will be evaluated for safety and tolerability before starting higher doses. Cohort A1: Participants will receive a single dose of 25 mg of SGR-1505 on Day 1 Cohort A2: Participants will receive a single dose of 50 mg of SGR-1505 on Day 1 Cohort A3: Participants will receive a single dose of 100 mg of SGR-1505 on Day 1 Cohort A4: Participants will receive a single dose of 150 mg of SGR-1505 on Day 1 Cohort A5: Participants will receive a single dose of 200 mg of SGR-1505 on Day 1 Cohort A6: Participants will receive a single dose of 300 mg of SGR-1505 on Day 1 Part B of this study will evaluate multiple ascending oral doses (MAD) up to 10 days. Six participants will enroll into each of the 3 MAD cohorts. All participants in the cohort will be evaluated for safety and tolerability prior to initiating higher doses. Part B will commence once the safety and tolerability of the 100 mg dose in Part A is established. Cohort B1: Participants will receive once daily dose of 75 mg of SGR-1505 for 10 days. Cohort B2: Participants will receive once daily dose of 150 mg of SGR-1505 for 10 days. Cohort B3: Participants will receive once daily dose of 300 mg of SGR-1505 for 10 days. Part D of this study will evaluate the effect of posaconazole (a CYP3A inhibitor) on the PK profile of SGR-1505. 200 mg SGR-1505 will be administered with a low dose of an antifungal drug called posaconazole in the fasted state. Cohort D1: Participants will receive orally single dose of 200 mg of SGR-1505 on Day 1 and 18. Participants will receive once daily single dose of 100 mg posaconazole on Day 9, Day 10, Day 11, Day 12, Day 13, Day 14, Day 15, Day 16, Day 17, Day 18, Day 19, Day 20, Day 21, Day 22, Day 23, Day 24, Day 25, Day 26. Part D will start after the completion of cohort 5 in Part A 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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ACTRN12623000358640