*Safety, Tolerability and Pharmacokinetics of BMS-986238 in Healthy Volunteers (QSC203717)
Research type
Research Study
Full title
A Randomized, Double-Blinded, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability, Effect of Food and Absolute Bioavailability of BMS-986238 in Healthy Participants
IRAS ID
1004360
Contact name
Head of Global Submission Management - Clinical Trials
Contact email
Sponsor organisation
Bristol-Myers Squibb Company
Eudract number
2020-004521-23
ISRCTN Number
ISRCTN17572332
Research summary
Background and study aims
The Sponsor is developing the test medicine, BMS-986238, for the potential treatment of various forms of cancer, including solid tumours and lymphomas (cancer of the lymphatic system). Cancer is a disease where cells in the body grow uncontrollably and may spread to other parts of the body. Cancer causes a wide variety of symptoms and can be fatal. This healthy volunteer study is testing the safety and tolerability of 2 different formulations (recipes) of the test medicine, and how these different recipes of test medicine are taken up by the body over time (the pharmacokinetics). It is also looking to assess the different effects of the test medicine when taken with and without food, and to measure the amount of the test medicine that is absorbed by the body when taken by mouth or injection.
Who can participate?
Healthy male and non-lactating female volunteers of non-childbearing potential, aged 18 to 55 years.
What does the study involve?
It was planned that the study would be split into 3 Parts (Parts A, B and C), involving up to 136 healthy volunteers. In Part A, up to 104 volunteers would be split into 9 groups and receive a single dose of test medicine or dummy medicine (placebo) by mouth. In Part B, up to 16 volunteers would receive two single doses of the test medicine by mouth given with or without food. In Part C, up to 16 volunteers would receive a single dose of the test medicine by mouth, and a single dose of test medicine as an injection into the arm. For all study parts, volunteers would enter the clinical unit on Day -2 (2 days before dosing) and are discharged 14 days after dosing. Parts B and C would involve 2 study periods, with a minimum of 35 days between the two single doses. After final discharge from the clinical unit, volunteers in all study parts would return to the clinic on Days 21, 28 and 35 for outpatient study visits, and on Day 42 for a final follow-up visit. Volunteers may return for additional visits if required based on data collected during the study. Volunteer’s blood and urine are collected throughout the study for analysis of the test medicine and for their safety. Volunteers are expected to be involved in the study for up to 16 weeks, from screening to the final follow up visit.
Please note that the study was terminated prior to Part B and Part C being initiated.
What are the possible risks and benefits of participating?
Participants get no medical benefit from taking part in the study. However, development of a cancer treatment may benefit the population as a whole. It is considered that the risk/benefit evaluation in this study supports the use of healthy volunteers. Full information on the possible side effects is provided to volunteers in the Participant Information Sheet/Informed Consent Form. Volunteers are closely monitored during the study and safety assessments are performed regularly.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
22/SC/0285
Date of REC Opinion
12 Apr 2022
REC opinion
Further Information Favourable Opinion