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
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT05530278
- Lead Sponsor
- AbbVie
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 24
- Body Mass Index (BMI) is ≥ 18.0 to ≤ 29.9 kg/m2 after rounding to the tenths 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).
- 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 any clinically significant sensitivity or allergy to any medication or food.
- History of any clinically significant condition listed in the protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ABBV-576 with Galicaftor + Navocaftor Galicaftor Participants will receive ABBV-576 for 14 consecutive days, with navocaftor + galicaftor for the latter 7 consecutive days. Navocaftor + Galicaftor with ABBV 576 Galicaftor Participants will receive Navocaftor + galicaftor for 14 consecutive days, with ABBV 576 for the latter 7 consecutive days. Navocaftor + Galicaftor with ABBV 576 Navocaftor Participants will receive Navocaftor + galicaftor for 14 consecutive days, with ABBV 576 for the latter 7 consecutive days. Optional: Midazolam with ABBV-576 + Navocaftor Navocaftor Participants will receive Midazolam alone and in combination with multiple doses of ABBV-576 + navocaftor. ABBV-576 with Galicaftor + Navocaftor ABBV-576 Participants will receive ABBV-576 for 14 consecutive days, with navocaftor + galicaftor for the latter 7 consecutive days. Optional: Navocaftor with ABBV 576 ABBV-576 Participants will receive Navocaftor for 14 consecutive days with ABBV 576 for the latter 7 consecutive days. Optional: Galicaftor with ABBV 576 ABBV-576 Participants will receive Galicaftor for 14 consecutive days, with ABBV 576 for the latter 7 consecutive days. Navocaftor + Galicaftor with ABBV 576 ABBV-576 Participants will receive Navocaftor + galicaftor for 14 consecutive days, with ABBV 576 for the latter 7 consecutive days. ABBV-576 with Galicaftor + Navocaftor Navocaftor Participants will receive ABBV-576 for 14 consecutive days, with navocaftor + galicaftor for the latter 7 consecutive days. Optional: Navocaftor with ABBV 576 Navocaftor Participants will receive Navocaftor for 14 consecutive days with ABBV 576 for the latter 7 consecutive days. Optional: Galicaftor with ABBV 576 Galicaftor Participants will receive Galicaftor for 14 consecutive days, with ABBV 576 for the latter 7 consecutive days. Optional: Midazolam with ABBV-576 + Navocaftor ABBV-576 Participants will receive Midazolam alone and in combination with multiple doses of ABBV-576 + navocaftor. Optional: Midazolam with ABBV-576 + Navocaftor Midazolam Participants will receive Midazolam alone and in combination with multiple doses of ABBV-576 + navocaftor.
- Primary Outcome Measures
Name Time Method Apparent terminal phase elimination rate constant (BETA or β) Up to Day 52 Apparent terminal phase elimination rate constant (BETA or β) will be assessed.
Time to maximum observed plasma concentration (Tmax) Up to Day 52 Tmax will be assessed.
Mean terminal phase elimination half-life (t1/2) Up to Day 52 T1/2 will be assessed.
Area under the plasma curve (AUC) Up to Day 52 AUC will be assessed.
Number of Participants With Adverse Events (AEs) Up to Day 82 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.
Maximum Plasma Concentration (Cmax) Up to Day 52 Cmax will be assessed.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Anaheim Clinical Trials LLC /ID# 248824
🇺🇸Anaheim, California, United States
Clinical Pharmacology of Miami /ID# 248823
🇺🇸Miami, Florida, United States
PPD Clinical Research Unit -Las Vegas /ID# 248853
🇺🇸Las Vegas, Nevada, United States
PPD Clinical Research Unit - Austin /ID# 248854
🇺🇸Austin, Texas, United States