Food Effect Study of BMS-984923 in Healthy Older Adult Volunteers

July 29, 2024 updated by: Allyx Therapeutics

A Randomized, Open-label, 2-period, Crossover, Pilot Food Effect Study of BMS-984923 in Healthy Older Adult Volunteers

This project is developing a novel disease-modifying compound for Alzheimer's disease (AD).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this study is to evaluate for an effect of food consumption on the pharmacokinetics profile of BMS984923. Safety and tolerability is also assessed.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • West Bend, Wisconsin, United States, 53095
        • Spaulding Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Men or women between the ages of 50 and 80 years, inclusive
  • No history of cognitive impairment
  • Capable of providing written informed consent and willing to comply with all study requirements and procedures
  • Participant is not pregnant, lactating, or of childbearing potential

Exclusion Criteria:

  • Body mass index (BMI) >38 kg/m2 or body weight <50 kg.
  • Significant cerebrovascular disease
  • Any significant neurologic disease
  • A current Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM V) diagnosis of active major depression, schizophrenia or bipolar disorder
  • Clinically significant or unstable medical condition
  • Any disorder or medication that could interfere with the absorption, distribution, metabolism or excretion of drugs
  • History of cholecystectomy
  • History of acute/chronic hepatitis B or C and/or carriers of hepatitis B (seropositive for hepatitis B surface antigen [HbsAg] or anti-hepatitis C virus [HCV] antibody).
  • Use of psychoactive medications
  • Use of medications with potential drug-drug interactions
  • Use of another investigational agent
  • Clinically significant abnormalities in screening laboratories
  • Any suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale
  • Acceptable Geriatric Depression Scale (GDS) score

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dose Under Fed Condition
Investigational Drug is administered with a meal
Drug: BMS-984923
Oral capsule
Active Comparator: Dose Under Fasted Condition
Investigational Drug is administered after fasting
Drug: BMS-984923
Oral capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Plasma Concentration (Cmax)
Time Frame: Up to 10 days after last dose
Maximum plasma concentration as determined by pharmacokinetic modeling
Up to 10 days after last dose
Time of Cmax (Tmax)
Time Frame: Up to 10 days after last dose
Time of Cmax as determined by pharmacokinetic modeling
Up to 10 days after last dose
Area Under the Curve from 0 to 24h (AUC 24h)
Time Frame: Up to 10 days after last dose
Plasma drug exposure as determined by pharmacokinetic modeling
Up to 10 days after last dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Laboratory abnormalities
Time Frame: 14 days
Safety
14 days
Electrocardiogram - QT Interval
Time Frame: 14 days
Safety
14 days
Incidence of Treatment Emergent Adverse Events (TEAE)
Time Frame: 14 days
Safety
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allyx Therapeutics

Collaborators

Michael J. Fox Foundation for Parkinson's Research

Investigators

  • Principal Investigator: Stephanie Post, MD, Principal Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2023

Primary Completion (Actual)

February 27, 2023

Study Completion (Estimated)

November 15, 2024

Study Registration Dates

First Submitted

March 24, 2023

First Submitted That Met QC Criteria

April 5, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

July 30, 2024

Last Update Submitted That Met QC Criteria

July 29, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALX-923-103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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