Navocaftor for Healthy Subjects (HS)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
PPD Clinical Research Unit - Austin /ID# 249538, Austin, TX
Healthy Subjects (HS)
Navocaftor - Drug
Eligibility
18+
All Sexes
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 objectives of this study are to assess the effect of food on the safety and pharmacokinetics of navocaftor and galicaftor.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Healthy Subjects (HS)

Study Objectives

5 Primary · 0 Secondary · Reporting Duration: Up to Day 38

Up to Day 38
Number of Participants with Adverse Events (AEs)
Up to Day 4
Area under the plasma curve (AUC)
Maximum Observed Plasma Concentration (Cmax)
Terminal Elimination Half-life (t1/2)
Time to Cmax (peak time, Tmax)

Trial Safety

Safety Progress

1 of 3

Other trials for Healthy Subjects (HS)

Trial Design

4 Treatment Groups

Part 1: Navocaftor with food
1 of 4
Part 2: Galicaftor without food
1 of 4
Part 2: Galicaftor with food
1 of 4
Part 1: Navocaftor without food
1 of 4
Experimental Treatment

24 Total Participants · 4 Treatment Groups

Primary Treatment: Navocaftor · No Placebo Group · Phase 1

Part 1: Navocaftor with food
Drug
Experimental Group · 1 Intervention: Navocaftor · Intervention Types: Drug
Part 2: Galicaftor without food
Drug
Experimental Group · 1 Intervention: Galicaftor · Intervention Types: Drug
Part 2: Galicaftor with food
Drug
Experimental Group · 1 Intervention: Galicaftor · Intervention Types: Drug
Part 1: Navocaftor without food
Drug
Experimental Group · 1 Intervention: Navocaftor · Intervention Types: Drug

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 38
Closest Location: PPD Clinical Research Unit - Austin /ID# 249538 · Austin, TX
Photo of Austin 1Photo of Austin 2Photo of Austin 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Healthy Subjects (HS)
0 CompletedClinical Trials

Who is running the clinical trial?

AbbVieLead Sponsor
803 Previous Clinical Trials
463,038 Total Patients Enrolled
16 Trials studying Healthy Subjects (HS)
1,362 Patients Enrolled for Healthy Subjects (HS)
ABBVIE INC.Study DirectorAbbVie
281 Previous Clinical Trials
112,325 Total Patients Enrolled
8 Trials studying Healthy Subjects (HS)
845 Patients Enrolled for Healthy Subjects (HS)

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a body mass index (BMI) of at least 18.0 to 32.
You have 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.