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NCT05538585 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess How Food Affects the Safety and Pharmacokinetics of Galicaftor and Navocaftor
A Phase 1 study of Healthy Volunteers, sponsored by AbbVie.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 2
- Study locations
NCT05538585: Completed Phase 1 study of Healthy Volunteers, sponsored by AbbVie.
NCT05538585 is a Phase 1 study of Healthy Volunteers that has completed, run by AbbVie. The registered enrollment target is 24 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05538585, a Phase 1 study of Healthy Volunteers, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
Cmax will be assessed.
Conditions Studied
Interventions
- DRUG Galicaftor
- DRUG Navocaftor
Study Locations (2)
Florida
- Clinical Pharmacology of Miami /ID# 249531 - Miami
Illinois
- Acpru /Id# 249532 - Grayslake
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2022-09-27 |
| Est. Completion | 2022-12-21 |
| Phase | Phase 1 |
What the finished NCT05538585 record still lists
NCT05538585 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Galicaftor is the first listed.
NCT05538585 reports a single indexed study location in Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT05538585 about?
NCT05538585 is a clinical study titled "A Study to Assess How Food Affects the Safety and Pharmacokinetics of Galicaftor and Navocaftor". 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 pharmaco...
What is the current status of trial NCT05538585?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2022-09-27. Estimated completion is 2022-12-21.
What conditions does trial NCT05538585 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT05538585?
The interventions under investigation include: Galicaftor (DRUG), Navocaftor (DRUG).
Who is sponsoring clinical trial NCT05538585?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05538585 being conducted?
This trial has 2 study locations across Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05538585's enrollment target sits among peer trials
24 204th of 283 higher than 66 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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