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Completed

NCT Number: NCT04926051

A Study to Assess the Safety, Tolerability and Drug Levels of BMS-986172 in Healthy and Obese Participants, Including an Assessment of the Effects of Food on BMS-986172 Absorption

The purpose of this study is to evaluate the safety, tolerability and drug levels of BMS-986172 and evaluate the effects of food on BMS-986172 absorption.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON Plc (Legacy PRA)

Lenexa, Kansas, 66215, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy participants as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, ECG, and clinical laboratory results as determined by the investigator or designee.
  • Participants in Part C must be first-generation Japanese participants. For the purpose of this study, first-generation Japanese is defined as native Japanese or first-generation Japanese living outside of Japan for <10 years.
  • BMI of ≥ 18 kg/m2 to ≤ 40.0 kg/m2, inclusive, at screening, except for high BMI cohort participants (Part B) which will be restricted to a BMI range of ≥ 30 kg/m2 to ≤ 40.0 kg/m2.

Exclusion criteria

  • Inability to tolerate the oral lipid meal or the testing conditions on Day -1, including but not limited to: bloating, nausea, vomiting, diarrhea, pain, or any discomfort due to oral lipid meal.
  • Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome.
  • History or presence of malignancy including hematological malignancies; participants with a history of basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence within 5 years will be allowed for inclusion, as judged by the investigator or designee.
  • Any significant acute or chronic medical illness.
  • History of SARS-CoV-2 infection (either suspected or confirmed) within 3 months prior to signing consent
  • Participants who have received a SARS-CoV-2 vaccine approved for Emergency Use Authorization by the US FDA that is not live attenuated may be considered for enrollment

Other protocol-defined inclusion/exclusion criteria apply

Treatment and study plan

BMS-986172

Drug

Specified dose on specified days

Placebo

Other

Specified dose on specified days

Primary outcomes

  1. Incidence of non-serious Adverse Events (AEs)

    Time frame: Up to 35 days

  2. Incidence of Serious Adverse Events (SAEs)

    Time frame: Up to 35 days

  3. Incidence of AEs leading to discontinuation of study treatment

    Time frame: Up to 35 days

  4. Incidence of clinically significant changes in vital signs: Body temperature

    Time frame: Up to 28 days

  5. Incidence of clinically significant changes in vital signs: Respiratory rate

    Time frame: Up to 28 days

  6. Incidence of clinically significant changes in vital signs: Blood pressure

    Time frame: Up to 28 days

  7. Incidence of clinically significant changes in vital signs: Heart rate

    Time frame: Up to 28 days

  8. Incidence of clinically significant changes in physical examination

    Time frame: Up to 28 days

  9. Incidence of clinically significant changes in clinical laboratory values: Hematology tests

    Time frame: Up to 28 days

  10. Incidence of clinically significant changes in clinical laboratory values: Chemistry tests

    Time frame: Up to 28 days

  11. Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests

    Time frame: Up to 28 days

  12. Incidence of clinically significant changes in clinical laboratory values: Serology tests

    Time frame: Up to 28 days

  13. Incidence of clinically significant changes in ECG parameters: QTcF

    Time frame: Up to 28 days

    QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave

Secondary outcomes

  1. Plasma concentrations of BMS-986172

    Time frame: Up to 28 days

  2. Maximum observed plasma concentration (Cmax)

    Time frame: Up to 28 days

  3. Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))

    Time frame: Up to 28 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 1, Double-blind, Placebo-controlled, Randomized, Single and Multiple Ascending Dose, and a Japanese Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-986172, Including an Open-Label Assessment of Relative Bioavailability and Food Effect on the Single-Dose Pharmacokinetics of BMS-986172 in Healthy and Obese Otherwise Healthy Participants

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 14, 2021
Registry last updated
Jun 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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