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CFTR Modulator

Navocaftor for Healthy Subjects (M23-492 FE Trial)

Phase 1
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 38
Awards & highlights

M23-492 FE Trial Summary

This trial is testing a new medication for people with Cystic Fibrosis. The objective is to see if the medication is safe and effective.

M23-492 FE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 38
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 38 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 curve (AUC)
Maximum Observed Plasma Concentration (Cmax)
Number of Participants with Adverse Events (AEs)
+2 more

M23-492 FE Trial Design

4Treatment groups
Experimental Treatment
Group I: Part 2: Galicaftor without foodExperimental Treatment1 Intervention
Participants will receive galicaftor administered without food
Group II: Part 2: Galicaftor with foodExperimental Treatment1 Intervention
Participants will receive galicaftor administered with food
Group III: Part 1: Navocaftor without foodExperimental Treatment1 Intervention
Participants will receive navocaftor administered without food
Group IV: Part 1: Navocaftor with foodExperimental Treatment1 Intervention
Participants will receive navocaftor administered with food
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Galicaftor
2022
Completed Phase 1
~50
Navocaftor
2022
Completed Phase 1
~50

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AbbVieLead Sponsor
958 Previous Clinical Trials
502,366 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
147,085 Total Patients Enrolled

Frequently Asked Questions

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

Might I be a suitable candidate to partake in this medical trial?

"For this medical trial, 24 participants of ages between 18 and 65 are being sought after. In order to be selected for the study, candidates must have a BMI within the range of 18.0 - 32.0 kg/ m2 after rounding, display overall good health based on physical exams as well as lab test results and an ECG reading."

Answered by AI

What is the current standing of Navocaftor with regards to US-based regulatory authorities?

"Our team at Power assigned Navocaftor a score of 1 since it is currently in Phase 1 and there exists limited data that can attest to its safety or efficacy."

Answered by AI

Is enrollment open for this clinical experiment?

"According to the clinicaltrials.gov website, this trial is no longer actively accepting volunteers; it was initially posted on September 27th 2022 and its last update occurred in November 18th of that same year. Although recruitment for this study has been suspended, over 800 other trials are still seeking participants."

Answered by AI

Is this study open to people younger than 85 years old?

"This clinical trial has imposed an age limit of 18 to 65 years old as inclusion criteria for participation."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
Florida
Texas
How old are they?
18 - 65
What site did they apply to?
Clinical Pharmacology of Miami /ID# 249531
PPD Clinical Research Unit - Austin /ID# 249538
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Assess How Food Affects the Safety and Pharmacokinetics of Galicaftor and Navocaftor
2022. "A Study to Assess How Food Affects the Safety and Pharmacokinetics of Galicaftor and Navocaftor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05538585.
~10 spots leftby Apr 2025
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