Healthy Volunteers
Conditions
Keywords
Galicaftor, Navocaftor, ABBV-576, Cystic Fibrosis
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.
Interventions
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Plasma Concentration (Cmax) | Up to Day 52 | Cmax will be assessed. |
| Time to maximum observed plasma concentration (Tmax) | Up to Day 52 | Tmax will be assessed. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed