Assessment of Multiple-Dose Pharmacokinetics and Safety of the Co-administration of Galicaftor, Navocaftor and ABBV-576 and Potential of ABBV-576 for CYP3A Induction in Healthy Volunteers
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 24
- Locations
- 4
- Primary Endpoint
- Apparent terminal phase elimination rate constant (BETA or β)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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).
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 any clinically significant sensitivity or allergy to any medication or food.
- •History of any clinically significant condition listed in the protocol.
Arms & Interventions
ABBV-576 with Galicaftor + Navocaftor
Participants will receive ABBV-576 for 14 consecutive days, with navocaftor + galicaftor for the latter 7 consecutive days.
Intervention: ABBV-576 (Drug)
ABBV-576 with Galicaftor + Navocaftor
Participants will receive ABBV-576 for 14 consecutive days, with navocaftor + galicaftor for the latter 7 consecutive days.
Intervention: Galicaftor (Drug)
ABBV-576 with Galicaftor + Navocaftor
Participants will receive ABBV-576 for 14 consecutive days, with navocaftor + galicaftor for the latter 7 consecutive days.
Intervention: Navocaftor (Drug)
Navocaftor + Galicaftor with ABBV 576
Participants will receive Navocaftor + galicaftor for 14 consecutive days, with ABBV 576 for the latter 7 consecutive days.
Intervention: Galicaftor (Drug)
Navocaftor + Galicaftor with ABBV 576
Participants will receive Navocaftor + galicaftor for 14 consecutive days, with ABBV 576 for the latter 7 consecutive days.
Intervention: ABBV-576 (Drug)
Navocaftor + Galicaftor with ABBV 576
Participants will receive Navocaftor + galicaftor for 14 consecutive days, with ABBV 576 for the latter 7 consecutive days.
Intervention: Navocaftor (Drug)
Optional: Navocaftor with ABBV 576
Participants will receive Navocaftor for 14 consecutive days with ABBV 576 for the latter 7 consecutive days.
Intervention: ABBV-576 (Drug)
Optional: Navocaftor with ABBV 576
Participants will receive Navocaftor for 14 consecutive days with ABBV 576 for the latter 7 consecutive days.
Intervention: Navocaftor (Drug)
Optional: Galicaftor with ABBV 576
Participants will receive Galicaftor for 14 consecutive days, with ABBV 576 for the latter 7 consecutive days.
Intervention: Galicaftor (Drug)
Optional: Galicaftor with ABBV 576
Participants will receive Galicaftor for 14 consecutive days, with ABBV 576 for the latter 7 consecutive days.
Intervention: ABBV-576 (Drug)
Optional: Midazolam with ABBV-576 + Navocaftor
Participants will receive Midazolam alone and in combination with multiple doses of ABBV-576 + navocaftor.
Intervention: ABBV-576 (Drug)
Optional: Midazolam with ABBV-576 + Navocaftor
Participants will receive Midazolam alone and in combination with multiple doses of ABBV-576 + navocaftor.
Intervention: Navocaftor (Drug)
Optional: Midazolam with ABBV-576 + Navocaftor
Participants will receive Midazolam alone and in combination with multiple doses of ABBV-576 + navocaftor.
Intervention: Midazolam (Drug)
Outcomes
Primary Outcomes
Apparent terminal phase elimination rate constant (BETA or β)
Time Frame: Up to Day 52
Apparent terminal phase elimination rate constant (BETA or β) will be assessed.
Time to maximum observed plasma concentration (Tmax)
Time Frame: Up to Day 52
Tmax will be assessed.
Mean terminal phase elimination half-life (t1/2)
Time Frame: Up to Day 52
T1/2 will be assessed.
Area under the plasma curve (AUC)
Time Frame: Up to Day 52
AUC will be assessed.
Number of Participants With Adverse Events (AEs)
Time Frame: 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)
Time Frame: Up to Day 52
Cmax will be assessed.
Secondary Outcomes
No secondary outcomes reported