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CFTR Modulator

Galicaftor for Healthy Subjects (ABBV-576 DDI 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 82
Awards & highlights

ABBV-576 DDI Trial Summary

This trial is testing a new combination therapy for Cystic Fibrosis, to see if it is safe and effective.

Eligible Conditions
  • Healthy Subjects

ABBV-576 DDI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 82
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 82 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Apparent terminal phase elimination rate constant (BETA or β)
Area under the plasma curve (AUC)
Maximum Plasma Concentration (Cmax)
+3 more

ABBV-576 DDI Trial Design

5Treatment groups
Experimental Treatment
Group I: Optional: Navocaftor with ABBV 576Experimental Treatment2 Interventions
Participants will receive Navocaftor for 14 consecutive days with ABBV 576 for the latter 7 consecutive days.
Group II: Optional: Midazolam with ABBV-576 + NavocaftorExperimental Treatment3 Interventions
Participants will receive Midazolam alone and in combination with multiple doses of ABBV-576 + navocaftor.
Group III: Optional: Galicaftor with ABBV 576Experimental Treatment2 Interventions
Participants will receive Galicaftor for 14 consecutive days, with ABBV 576 for the latter 7 consecutive days.
Group IV: Navocaftor + Galicaftor with ABBV 576Experimental Treatment3 Interventions
Participants will receive Navocaftor + galicaftor for 14 consecutive days, with ABBV 576 for the latter 7 consecutive days.
Group V: ABBV-576 with Galicaftor + NavocaftorExperimental Treatment3 Interventions
Participants will receive ABBV-576 for 14 consecutive days, with navocaftor + galicaftor for the latter 7 consecutive days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Midazolam
2018
Completed Phase 4
~1910
ABBV-576
2022
Completed Phase 1
~30
Navocaftor
2022
Completed Phase 1
~50
Galicaftor
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
954 Previous Clinical Trials
501,081 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
394 Previous Clinical Trials
145,915 Total Patients Enrolled

Frequently Asked Questions

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

Is this research study being conducted at various venues in the city?

"This study has four distinct sites that are currently taking on participants: Anaheim Clinical Trials LLC /ID# 248824 in Anaheim, PPD Clinical Research Unit - Austin /ID# 248854 in Austin, and PPD Clinical Research Unit -Las Vegas /ID# 248853 in Las Vegas. Additionally, there is one other enrolment centre available for this trial."

Answered by AI

Is this investigation open to those aged 18 or older?

"This medical trial is actively seeking participants aged 18 and older, but no more than 65 years of age."

Answered by AI

To what extent might Galicaftor be hazardous to a person's health?

"At this time, there is limited clinical data available on Galicaftor's efficacy and safety. As such, our team at Power assigned it a rating of 1 out of 3."

Answered by AI

How many individuals have been recruited to participate in this clinical trial?

"This clinical trial necessitates 60 qualified participants. Those interested can register at Anaheim Clinical Trials LLC /ID# 248824 in Anaheim, California and PPD Clinical Research Unit - Austin /ID# 248854 in Austin, Texas."

Answered by AI

What characteristics must a potential participant possess to be deemed eligible for this trial?

"The clinical trial is looking to enlist 60 volunteers with a healthy BMI between 18 and 29.9 kg/m2, who are otherwise in good health based on medical history, physical examination, vitals signs data, laboratory analysis results, and ECG readings."

Answered by AI

Is this research actively recruiting participants?

"According to clinicaltrials.gov, this trial is actively recruiting participants as of October 24th 2022, following its initial posting on September 20th the same year."

Answered by AI

Who else is applying?

What site did they apply to?
Anaheim Clinical Trials LLC /ID# 248824
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
What state do they live in?
California
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the Pharmacokinetics and Safety of Co-administered Oral Galicaftor, Navocaftor, and ABBV-576 in Healthy Adults for the Treatment of Cystic Fibrosis
2022. "A Study to Assess the Pharmacokinetics and Safety of Co-administered Oral Galicaftor, Navocaftor, and ABBV-576 in Healthy Adults for the Treatment of Cystic Fibrosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05530278.
~10 spots leftby Apr 2025
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