Galicaftor for Healthy Subjects (HS)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Anaheim Clinical Trials LLC /ID# 248824, Anaheim, CA
Healthy Subjects (HS)+1 More
Galicaftor - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

Cystic Fibrosis (CF) is a rare, life-threatening, genetic disease that affects the lungs and digestive system, significantly impairing the quality of life, with those affected having a median age of death at 40. The main objectives of this study are to assess the safety and pharmacokinetics of the combination therapy of galicaftor/navocaftor/ABBV-576.

Eligible Conditions

  • Healthy Subjects (HS)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Healthy Subjects (HS)

Study Objectives

6 Primary · 0 Secondary · Reporting Duration: Up to Day 82

Up to Day 52
Apparent terminal phase elimination rate constant (BETA or β)
Area under the plasma curve (AUC)
Maximum Plasma Concentration (Cmax)
Mean terminal phase elimination half-life (t1/2)
Time to maximum observed plasma concentration (Tmax)
Up to Day 82
Number of Participants With Adverse Events (AEs)

Trial Safety

Safety Progress

1 of 3

Other trials for Healthy Subjects (HS)

Trial Design

5 Treatment Groups

Optional: Galicaftor with ABBV 576
1 of 5
Navocaftor + Galicaftor with ABBV 576
1 of 5
Optional: Navocaftor with ABBV 576
1 of 5
ABBV-576 with Galicaftor + Navocaftor
1 of 5
Optional: Midazolam with ABBV-576 + Navocaftor
1 of 5
Experimental Treatment

60 Total Participants · 5 Treatment Groups

Primary Treatment: Galicaftor · No Placebo Group · Phase 1

Optional: Galicaftor with ABBV 576Experimental Group · 2 Interventions: ABBV-576, Galicaftor · Intervention Types: Drug, Drug
Navocaftor + Galicaftor with ABBV 576Experimental Group · 3 Interventions: Navocaftor, ABBV-576, Galicaftor · Intervention Types: Drug, Drug, Drug
Optional: Navocaftor with ABBV 576Experimental Group · 2 Interventions: Navocaftor, ABBV-576 · Intervention Types: Drug, Drug
ABBV-576 with Galicaftor + NavocaftorExperimental Group · 3 Interventions: Navocaftor, ABBV-576, Galicaftor · Intervention Types: Drug, Drug, Drug
Optional: Midazolam with ABBV-576 + NavocaftorExperimental Group · 3 Interventions: Navocaftor, ABBV-576, Midazolam · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Midazolam
2018
Completed Phase 4
~1920

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to day 82
Closest Location: Anaheim Clinical Trials LLC /ID# 248824 · Anaheim, CA
N/AFirst Recorded Clinical Trial
1 TrialsResearching Healthy Subjects (HS)
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · Female Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a body mass index (BMI) of 18.0 to 29.9 kg/m2.
A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.