Bristol-Myers Squibb Registers New Phase I Clinical Trial (NCT07629999) to Evaluate Safety and Pharmacokinetics of BMS-986533, Including Food and pH Effects and DDI Potential

August 2, 2026

ClinicalTrials.gov USA

Overview

Bristol-Myers Squibb has registered a Phase I clinical trial (NCT07629999) on ClinicalTrials.gov to evaluate the safety and pharmacokinetics of BMS-986533 in healthy participants. The study will also assess the effects of food and pH on its relative bioavailability, and its potential for drug-drug interactions. The record was last updated on July 24, 2026, with the last verification occurring in July 2026.

In Depth

Key Findings

Bristol-Myers Squibb has registered a Phase I clinical trial (NCT07629999) on ClinicalTrials.gov to evaluate the safety and pharmacokinetics (PK) of the investigational drug BMS-986533 in healthy participants. This study aims not only to elucidate the drug’s fundamental characteristics but also to comprehensively assess the impact of food intake and changes in gastric pH on its relative bioavailability, as well as the potential for drug-drug interactions.

Technical / Clinical Details

This Phase I trial is designed to establish the safety profile and pharmacokinetics of BMS-986533 following single and multiple doses. Pharmacokinetic evaluations include measuring key PK parameters such as blood concentration profiles, half-life, clearance, and volume of distribution. Particularly important is the assessment of food and pH effects on drug absorption. This information is crucial for developing effective oral dosing strategies and providing appropriate instructions to patients regarding medication with meals. Furthermore, early-stage evaluation of potential drug-drug interactions with other common medications helps predict the safety of future combination therapies and identify potential risks. While the number of participants and detailed protocol are not publicly disclosed, Phase I trials typically involve a small number of healthy volunteers.

Background & Context

In new drug development, detailed pharmacokinetic and safety data obtained from Phase I trials provide an indispensable foundation for the design and success of later-stage clinical trials. Early assessment of food effects and drug-drug interactions is vital to prevent unexpected issues in clinical drug use and optimize patient treatment outcomes. Registration on public databases like ClinicalTrials.gov plays an internationally significant role in enhancing transparency and accountability across the pharmaceutical industry, and in preventing research duplication.

Strategic Significance & Outlook

The results from this Phase I trial will contribute to important decision-making for further clinical development of BMS-986533. If a favorable safety profile, predictable pharmacokinetics, and manageable food effects or drug-drug interactions are confirmed, the drug is highly likely to advance to Phase II trials in specific patient populations. This thorough early-stage evaluation is a crucial step towards ultimately delivering safe and effective therapeutic agents to patients.

Source: https://clinicaltrials.gov/study/NCT07629999

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