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

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Jul 2023

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

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
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2023

Completed
Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

May 10, 2023

Last Update Submit

May 11, 2026

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)

Local Institution - 0001

Nottingham, Nottinghamshire, NG11 6JS, United Kingdom

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
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

September 29, 2023

Study Completion

September 29, 2023

Last Updated

May 13, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
See Plan Description
Access Criteria
See Plan Description
More information

Locations

GB(1)