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Part 1: Afimetoran followed by phenytoin + afimetoran for Healthy Subjects

Phase 1
Recruiting
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 124 days
Awards & highlights

Study Summary

This trial will study how 2 drugs interact with each other when taken together or separately.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 124 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 124 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T])
Maximum observed plasma concentration (Cmax)
Secondary outcome measures
Apparent total body clearance of the drug from the plasma (CLT/F)
Number of participants with adverse events (AEs)
Number of participants with clinical laboratory abnormalities
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part 2: Midazolam followed by afimetoran + midazolamExperimental Treatment2 Interventions
Group II: Part 1: Afimetoran followed by phenytoin + afimetoranExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Phenytoin
2023
Completed Phase 4
~830
Midazolam
2018
Completed Phase 4
~1910

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,638 Previous Clinical Trials
4,128,464 Total Patients Enrolled

Media Library

Part 1: Afimetoran followed by phenytoin + afimetoran Clinical Trial Eligibility Overview. Trial Name: NCT05901714 — Phase 1
Healthy Subjects Research Study Groups: Part 1: Afimetoran followed by phenytoin + afimetoran, Part 2: Midazolam followed by afimetoran + midazolam
Healthy Subjects Clinical Trial 2023: Part 1: Afimetoran followed by phenytoin + afimetoran Highlights & Side Effects. Trial Name: NCT05901714 — Phase 1
Part 1: Afimetoran followed by phenytoin + afimetoran 2023 Treatment Timeline for Medical Study. Trial Name: NCT05901714 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any restrictions on who may participate in this research?

"Eligible participants of this medical trial should be within the ages of 18 and 55, possess general healthiness, and up to 50 individuals will be allowed admittance."

Answered by AI

Is enrollment for this experiment actively accepting participants?

"Affirmative. According to clinicaltrials.gov, this medical experiment is still recruiting participants after it was initially posted on June 19th 2023 and most recently updated on July 12th 2023. The study site requires 50 volunteers from 1 facility."

Answered by AI

To what capacity has the clinical trial been populated?

"Affirmative. Clinicaltrials.gov records reveal that this clinical trial, which was first made public on June 19th 2023 is open for recruitment. The study requires 50 volunteers to participate at a single location."

Answered by AI

Are there age restrictions for the subjects of this experiment?

"This study is only open to individuals aged 18-55. Conversely, there are 55 trials available for minors and 370 studies accepting those above 65 years old."

Answered by AI

What is the ultimate purpose of this clinical research?

"This medical research will gauge the Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T]) over a maximum period of 53 days. As secondary objectives, Terminal half-life (T-Half), Time to attain maximum observed plasma concentration (Tmax) and Number of participants with electrocardiogram (ECG) abnormalities are also being measured in both Parts 1 and 2."

Answered by AI

Has the FDA sanctioned Part 2: Midazolam plus afimetoran + midazolam for use?

"Our team at Power assigned Part 2: Midazolam followed by afimetoran + midazolam a score of 1 due to the limited clinical data that exists supporting its safety and efficacy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the Effect of Phenytoin on the Drug Levels of Afimetoran and the Effect of Afimetoran on the Drug Levels of Midazolam
2023. "A Study to Assess the Effect of Phenytoin on the Drug Levels of Afimetoran and the Effect of Afimetoran on the Drug Levels of Midazolam". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05901714.
~27 spots leftby Apr 2025
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