A Study to Assess How Food Affects the Safety and Pharmacokinetics of Galicaftor and Navocaftor (M23-492 FE)

A Food-Effect Study for the Safety and Assessment of Pharmacokinetics of Navocaftor and Galicaftor.

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Navocaftor; Drug: Galicaftor

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33014
      • Clinical Pharmacology of Miami /ID# 249531
  • Illinois
    • Grayslake, Illinois, United States, 60030
      • Acpru /Id# 249532

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Body Mass Index (BMI) is => 18.0 to <= 32.0 kg/ m2 after rounding to the tenth's decimal.
• 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).

Exclusion Criteria:

• History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic, or psychiatric disease or disorder, or any uncontrolled medical illness.
• History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption [e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.].
• Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Navocaftor with food; Participants will receive navocaftor administered with food	Drug: Navocaftor; Oral; Other Names: ABBV-3067
Experimental: Part 1: Navocaftor without food; Participants will receive navocaftor administered without food	Drug: Navocaftor; Oral; Other Names: ABBV-3067
Experimental: Part 2: Galicaftor with food; Participants will receive galicaftor administered with food	Drug: Galicaftor; Oral; Other Names: ABBV-2222
Experimental: Part 2: Galicaftor without food; Participants will receive galicaftor administered without food	Drug: Galicaftor; Oral; Other Names: ABBV-2222

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Plasma Concentration (Cmax)	Cmax will be assessed.	Up to Day 4
Time to Cmax (peak time, Tmax)	Tmax will be assessed.	Up to Day 4
Terminal Elimination Half-life (t1/2)	Terminal elimination half-life (t1/2) will be assessed.	Up to Day 4
Area under the plasma curve (AUC)	AUC will be assessed.	Up to Day 4
Number of Participants with Adverse Events (AEs)	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.	Up to Day 38

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2022
• Primary Completion (Actual): December 21, 2022
• Study Completion (Actual): December 21, 2022

Study Registration Dates

• First Submitted: September 12, 2022
• First Submitted That Met QC Criteria: September 12, 2022
• First Posted (Actual): September 14, 2022

Study Record Updates

• Last Update Posted (Estimate): January 16, 2023
• Last Update Submitted That Met QC Criteria: January 12, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Galicaftor; Navicaftor; ABBV-3067; ABBV-2222
• Other Study ID Numbers: M23-492

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes