NCT04175925

Brief Summary

A Study assessing the drug levels and drug effects of variable doses of BMS-986322 in Healthy Participants compared to a placebo. The study also assesses how BMS-986322 affects the body with food and its acidity levels.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

November 15, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 25, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2021

Completed
Last Updated

May 31, 2022

Status Verified

May 1, 2022

Enrollment Period

1.7 years

First QC Date

November 13, 2019

Last Update Submit

May 26, 2022

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (20)

  • Incidence of Death

    up to 12 months

  • Incidence of Adverse Effects (AEs)

    up to 12 months

  • Incidence of Adverse Events leading to discontinuation

    up to 12 months

  • Incidence of Serious Adverse Events (SAEs)

    up to 12 months

  • Vital signs of body temperature

    up to 12 months

  • Vital signs of blood pressure

    up to 12 months

  • Vital signs of respiratory rate

    up to 12 months

  • Number of Participants with abnormal physical examinations

    up to 12 months

  • Number of clinically significant changes in Electrocardiograms (ECGs)

    up to 12 months

  • Number of clinically significant changes in lab assessment of blood serum

    up to 12 months

  • Number of clinically significant changes in lab assessment of urine

    up to 12 months

  • Number of Clinically significant changes in lab assessment of blood

    up to 12 months

  • Maximum concentration (Cmax) of BMS-986322 in Part C

    up to 12 months

  • Time of maximum concentration (Tmax) of BMS-986322 in Part C

    up to 12 months

  • Terminal elimination rate constant (Lambda_z) of BMS-986322 in Part C

    up to 12 months

  • Terminal elimination half-life (T-Half) of BMS-986322 in Part C

    up to 12 months

  • Area under the plasma concentration-time curve extrapolated to infinity [AUC(INF)] of BMS-986322 in Part C

    up to 12 months

  • Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration [AUC(0-T)] of BMS-986322 in Part C

    up to 12 months

  • Apparent oral clearance (CL/F) of BMS-986322 in Part C

    up to 12 months

  • Apparent volume of distrubution at terminal phase (Vz/F) of BMS-986322 in Part C

    up to 12 months

Study Arms (3)

Part A: BMS-986322

EXPERIMENTAL
Drug: BMS-986322Other: BMS-986322 Placebo

Part B: BMS-986322 Placebo

EXPERIMENTAL
Drug: BMS-986322Other: BMS-986322 Placebo

Part C: BMS-986322 with famotidine

EXPERIMENTAL
Drug: BMS-986322Drug: famotidine

Interventions

BMS-986322DRUG

Specified Dose on Specified Days

Part A: BMS-986322Part B: BMS-986322 PlaceboPart C: BMS-986322 with famotidine
BMS-986322 PlaceboOTHER

Specified Dose on Specified Days

Part A: BMS-986322Part B: BMS-986322 Placebo
famotidineDRUG

Specified Dose on Specified Days

Part C: BMS-986322 with famotidine

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
  • Body mass index (BMI) of 18.0 kg/m\^2 to 32.0 kg/m\^2, inclusive, and body weight ≥ 50 kg, at screening
  • Women and men must agree to follow methods of contraception.

You may not qualify if:

  • Any significant acute or chronic medical illness
  • History of recent infection
  • History of allergy to BMS-986322 or other compounds

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICON (LPRA) - Lenexa

Lenexa, Kansas, 66219, United States

Location

Related Links

MeSH Terms

Interventions

Famotidine

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2019

First Posted

November 25, 2019

Study Start

November 15, 2019

Primary Completion

July 13, 2021

Study Completion

July 13, 2021

Last Updated

May 31, 2022

Record last verified: 2022-05

Locations

US(1)