Effect of Food on Absorption of 2-(3-(3,5-dimethyltriazol-4-yl)-5-((s)-oxan-4-yl(phenyl)methyl)pyrido(3,2-b)indol-7-yl)propan-2-ol in Advanced Solid Tumors Participants

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What is this study about?

The trial involves participants who have Advanced Solid Tumors, which are cancers that have grown beyond their original location and cannot be removed by surgery. The investigational medicine being examined is an oral capsule that contains the drug BMS-986158, a type of BET‑inhibitor designed to interfere with proteins that help cancer cells grow.

The purpose of the study is to determine how food influences the bioavailability of the medication, meaning how much of the drug reaches the bloodstream when taken. Each participant will receive a single dose of the capsule on two separate occasions: once after eating a high‑fat, high‑calorie meal and once after an overnight fast, with the order decided randomly. Blood will be drawn after each dose to measure drug levels, and safety will be checked by monitoring any side effects or health problems that occur during the short observation period.

1 initial study visit

you will attend an initial visit after joining the study. during this visit you will give informed consent, provide your medical history, and undergo baseline examinations such as blood tests and physical measurements.

2 randomization to study sequence

after the initial assessments you will be randomly assigned to one of two sequences. the sequences determine whether you receive the medication while fasted first and fed later, or fed first and fasted later.

3 first dosing period

you will receive a single oral dose of bms-986158 in a 3 mg soft gelatin capsule.

if your assigned condition is fasted, you will fast overnight (no food or drink except water) before taking the capsule with a glass of water and will remain without food for several hours after dosing.

if your assigned condition is fed, you will eat a high‑fat, high‑calorie meal as instructed, then take the capsule with a glass of water shortly after the meal.

blood samples will be taken at multiple time points after the dose to measure how the drug is absorbed in your body.

4 washout period

after the first dosing period you will have a washout interval during which no study medication is taken. this interval allows the drug to be cleared from your system before the next dosing period.

5 second dosing period

you will receive a second single oral dose of bms-986158 3 mg capsule under the opposite condition from the first period (fed if the first was fasted, or fasted if the first was fed).

the same procedures for taking the medication and for blood sampling will be followed as in the first dosing period.

6 safety monitoring throughout the study

throughout both dosing periods you will be asked to report any side effects or health changes.

regular safety checks, including vital signs and laboratory tests, will be performed to monitor your well‑being.

7 final study visit

at the end of the study you will attend a final visit for concluding examinations, repeat laboratory tests, and a summary of the study procedures you completed.

Who Can Join the Study?

  • Be at least 18 years old when you sign the consent form.
  • Have a doctor‑confirmed (by testing your tissue or cells) advanced solid tumor that cannot be removed or has spread, and that can be seen on scans or measured; you must have already tried standard treatments that did not work, could not be used, or were not tolerated.
  • Show a clear sign of tumor growth on recent scans, described as radiographically documented progressive disease, after your most recent therapy.
  • Have an ECOG performance status of 0 or 1, meaning you are fully active (0) or able to walk and take care of yourself but cannot do very strenuous activities (1).
  • Agree to eat a standard high‑fat, high‑calorie meal before taking the study drug (for example: two fried eggs, two strips of bacon, toast with butter, hash browns, and whole milk).

Who Cannot Join the Study?

  • Having a gastrointestinal disease (a problem with the stomach or intestines) now or in the past three months.
  • Having a second malignancy (another cancer) at the same time as the study cancer.
  • Having an uncontrolled or significant cardiovascular disease (serious heart or blood‑vessel problems).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Hm Sanchinarro Madrid Spain

Other Sites

Site Name City Country Status
Hjpzwpsv Vrln dyzkqmui Barcelona Spain
Hbymecvw Uidecclngvcce Fxqyygghl Jgnywwu Dahr Madrid Spain
Hmsuevwd Uzluidwskdycd 1r Df Onpmezk Madrid Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not recruiting
15.01.2024

Trial locations

BMS-986158 is an experimental oral medication that belongs to a class called BET inhibitors. In this study, participants with advanced solid tumors took a single capsule of this drug. The researchers wanted to see how much of the medicine entered the bloodstream when it was taken on an empty stomach compared with after eating a high‑fat, high‑calorie meal. By comparing these two conditions, the trial helps determine whether food affects the drug’s absorption and overall effectiveness.

Advanced solid tumors – Advanced solid tumors are cancers that form a solid mass in organs or tissues such as the lung, breast, colon, or pancreas. They have grown beyond the original site and may involve nearby structures or spread to distant parts of the body. As the disease progresses, the tumor can enlarge, invade surrounding tissue, and form new lesions in other organs. This stage often reflects a more widespread involvement compared with early‑stage disease. The growth pattern can be irregular, and the cancer cells continue to divide and survive despite the body’s defenses.

Trial ID:
2023-506661-65-00
Protocol code:
CA011-1010
Trial Phase:
Human Pharmacology (Phase I) – Other

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