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CFTR Modulator

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 (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
No Placebo-Only Group

Summary

This trial tests a combination of three drugs to help people with cystic fibrosis. The goal is to see if these drugs can fix the faulty protein in their cells, improving lung and digestive function. Trikafta is a combination of three drugs: elexacaftor, tezacaftor, and ivacaftor, and it targets the F508del mutation of the CFTR gene.

Eligible Conditions
  • Healthy Subjects

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AbbVieLead Sponsor
1,035 Previous Clinical Trials
523,020 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
456 Previous Clinical Trials
163,669 Total Patients Enrolled
~7 spots leftby Dec 2025
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