Cancers, including solid tumours and lymphomas Cancer
Conditions
Interventions
Participants received the following treatments.
1. Single oral dose of placebo for BMS-986238 Formulation A in the fasted state (Part A)
2. Single oral dose of placebo for BMS-986238 Formulation B in
Sponsors
Bristol-Myers Squibb (Belgium)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Must provide written informed consent 2. Healthy males healthy females of non-childbearing potential 3. Aged 18 - 55 years, inclusive, at the time of signing the informed consent form 4. Body mass index (BMI) of 18.0 - 32.0 kg/m² as measured at screening 5. A negative PCR or rapid antigen test for COVID-19 at screening and admission 6. Participants with a previous history of COVID-19 infection, must have been symptom-free for a minimum of 4 weeks before dosing, and did not experience a serious complication of the infection 7. Has received all doses of COVID-19 vaccines in compliance with national vaccination policy 8. Must agree to adhere to the contraception requirements defined in the protocol
Exclusion criteria
Exclusion criteria: 1. Any significant acute or chronic medical illness, including viral infection or seasonal allergies 2. History of diabetes mellitus, severe hypertriglyceridemia, acute or chronic pancreatitis, pancreatic exocrine disorder 3. Known or suspected autoimmune disorder, including but not limited to rheumatoid arthritis, fibromyalgia, systemic lupus erythematosus, polymyalgia rheumatic, giant cell arteritis, Behcet’s disease, dermatomyositis, multiple sclerosis, moderate to severe asthma, any autoimmune vasculitis, autoimmune hepatitis, autoimmune uveitis, autoimmune thyroiditis, or any other active autoimmune disease for which a participant requires medical follow-up or medical treatment 4. Any history of known or suspected congenital or acquired immunodeficiency state or condition that may compromise the participant’s immune status (eg, history of splenectomy) 5. Have been treated with systemic steroids, immunosuppressant therapies, or chemotherapeutic agents within 3 months prior to screening or is expected to receive these agents during the study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies) 6. Any participant with clinically significant symptoms of COVID-19 in the last 4 weeks, including but not limited to fever, new and persistent cough, breathlessness or loss of taste or smell, as per the judgement of the investigator 7. Any participant with a temperature of >37.5°C (confirmed by repeat after 15 minutes) at screening or admission 8. History of Gilbert’s syndrome 9. Current or recent (within 3 months of study intervention administration) gastrointestinal disease, including severe peptic ulcer disease, gastroesophageal reflux disease, or other gastric acid hypersecretory conditions requiring treatment 10. Any major surgery within 12 weeks of study intervention administration 11. Any gastrointestinal surgery that could impact upon the absorption of study drug. Appendectomy and cholecystectomy performed > 12 weeks prior to study intervention administration are permissible 12. Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (eg, basal cell skin cancer). Participants under evaluation for possible malignancy are not eligible 13. Donation of blood to a blood bank or in a clinical study (except a screening visit) within 90 days of study intervention administration (within 2 weeks for plasma only) or loss of greater than 400 mL of blood 14. Blood transfusion within 6 weeks of study intervention administration 15. Inability to be venipunctured and/or tolerate venous access 16. Inability to tolerate oral medication 17. Have received inactivated vaccinations (eg, pneumococcal) within 30 days prior to randomization or received live vaccinations within 30 days prior to screening. The use of inactivated seasonal influenza vaccines (eg, Fluzone®) will be permitted on the study without restriction. COVID-19 vaccines are permitted as long as they are not administered within 7 days prior to Day 1 (of Period 1, when applicable), during the study, and until at least Day 42 after the last dose or until receptor occupancy (RO) is at or projected to be at baseline level or at a level deemed clinically safe based on emerging PK, RO, and safety data, whichever is longer 18. Current smokers or user of any tobacco- or nicotine-containing products within 3 months of study intervention administration 19. Recent (within 6 months of study intervention admi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following primary outcome measures were planned but not achieved due to early termination of the study: 1. Incidence of adverse events, serious adverse events and adverse events leading to discontinuation and deaths from the time of signing the informed consent form until discharge from the study. 2. Incidence of abnormalities in clinical laboratory values measured using participant venous blood or urine samples from the time of signing the informed consent form and at multiple time points until discharge from the study. 3. Pharmacokinetic parameters Tmax, Cmax, AUC(0-T), AUC(INF), T-HALF, CLT/F, and Vz/F (all study parts) and CLR (Part A) and Fed;Fasted geometric mean rations for Cmax and AUC (Part B only) for BMS-986238 in plasma and urine samples from pre-dose and at multiple time points until discharge from the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures were planned but not achieved due to early termination of the study: 1. Incidence of adverse events, serious adverse events and adverse events leading to discontinuation and deaths from the time of signing the informed consent form until discharge from the study. 2. Incidence of abnormalities in clinical laboratory values measured using participant venous blood or urine samples from the time of signing the informed consent form and at multiple time points until discharge from the study. 3. Absolute oral bioavailability (F) of BMS-986238 in plasma samples from pre-dose and at multiple time points during the study. 4. Pharmacokinetic parameters Tmax, Cmax, AUC(0-T), AUC(INF), T-HALF, CLT/F (oral), CLT (IV), Vz (IV) and apparent volume of distribution at steady state (Vss) (IV) of BMS-986238 following an oral dose or an IV infusion in plasma samples from pre-dose and at multiple time points until discharge from the study. | — |
Countries
England, United Kingdom
Contacts
Public ContactHead of Global Submission Management - Clinical Trials
Outcome results
None listed