NCT05866627

Brief Summary

The purpose of this study is to confirm there is no significant effect of gastric pH changes of famotidine on the drug levels of afimetoran in healthy participants.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
Completed

Started Jul 2023

Longer than P75 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
recruiting

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

May 10, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 19, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

July 4, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

January 22, 2025

Status Verified

January 1, 2025

Enrollment Period

2.7 years

First QC Date

May 10, 2023

Last Update Submit

January 20, 2025

Conditions

Healthy Volunteers

Keywords

BMS-986256FamotidineGastric pH

Outcome Measures

Primary Outcomes (3)

  • Maximum observed plasma concentration (Cmax)

    Up to 20 Days

  • Time to attain maximum observed plasma concentration (Tmax)

    Up to 20 Days

  • Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T])

    Up to 20 Days

Secondary Outcomes (4)

  • Number of participants with adverse events (AEs)

    Up to 52 Days

  • Number of participants with clinical laboratory abnormalities

    Up to 52 Days

  • Number of participants with vital sign abnormalities

    Up to 52 Days

  • Number of participants with electrocardiogram (ECG) abnormalities

    Up to 52 Days

Study Arms (4)

Afimetoran, followed by famotidine + afimetoran

EXPERIMENTAL
Drug: FamotidineDrug: Afimetoran

Famotidine + afimetoran, followed by afimetoran

EXPERIMENTAL
Drug: FamotidineDrug: Afimetoran

Afimetoran

EXPERIMENTAL
Drug: Afimetoran

Famotidine, followed by afimetoran

EXPERIMENTAL
Drug: FamotidineDrug: Afimetoran

Interventions

FamotidineDRUG

Specified dose on specified days

Also known as: Pepcid
Afimetoran, followed by famotidine + afimetoranFamotidine + afimetoran, followed by afimetoranFamotidine, followed by afimetoran
AfimetoranDRUG

Specified dose on specified days

Also known as: BMS-986256
AfimetoranAfimetoran, followed by famotidine + afimetoranFamotidine + afimetoran, followed by afimetoranFamotidine, followed by afimetoran

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Weight ≥ 50 kilograms (kg), at screening and first admission, and body mass index between 18.0 kilogram per square meter (kg/m\^2) and 32.0 kg/m\^2, inclusive, at screening.
  • A negative QuantiFERON-TB Gold test result at screening or documentation of a negative result within 3 months before screening.
  • Normal renal function at screening as evidenced by an estimated glomerular filtration rate (eGFR) ≥ 80 milliliter per minute (mL/min)/1.732 m\^2 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula.

You may not qualify if:

  • Any significant acute or chronic medical illness.
  • Current or recent (within 3 months of study drug administration) gastrointestinal (GI) disease that could impact upon the absorption of study treatment.
  • GI surgery, including cholecystectomy, that could impact upon the absorption of study treatment, at the investigator's discretion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quotient Sciences

Nottingham, Nottinghamshire, NG11 6JS, United Kingdom

RECRUITING

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

Central Study Contacts

BMS Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

855-907-3286Clinical.Trials@bms.com

First line of the email MUST contain the NCT# and Site #.

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2023

First Posted

May 19, 2023

Study Start

July 4, 2023

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

January 22, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

Locations

GB(1)