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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Galicaftor
* Drug: ABBV-576
* Drug: Navocaftor
* Drug: Midazolam


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABBV-576 with Galicaftor + Navocaftor<br>Participants will receive ABBV-576 for 14 consecutive days, with navocaftor + galicaftor for the latter 7 consecutive days. | Drug: Galicaftor<br>* Oral<br>Drug: ABBV-576<br>* Oral<br>Drug: Navocaftor<br>* Oral<br>|
| Experimental: Navocaftor + Galicaftor with ABBV 576<br>Participants will receive Navocaftor + galicaftor for 14 consecutive days, with ABBV 576 for the latter 7 consecutive days. | Drug: Galicaftor<br>* Oral<br>Drug: ABBV-576<br>* Oral<br>Drug: Navocaftor<br>* Oral<br>|
| Experimental: Optional: Navocaftor with ABBV 576<br>Participants will receive Navocaftor for 14 consecutive days with ABBV 576 for the latter 7 consecutive days. | Drug: ABBV-576<br>* Oral<br>Drug: Navocaftor<br>* Oral<br>|
| Experimental: Optional: Galicaftor with ABBV 576<br>Participants will receive Galicaftor for 14 consecutive days, with ABBV 576 for the latter 7 consecutive days. | Drug: Galicaftor<br>* Oral<br>Drug: ABBV-576<br>* Oral<br>|
| Experimental: Optional: Midazolam with ABBV-576 + Navocaftor<br>Participants will receive Midazolam alone and in combination with multiple doses of ABBV-576 + navocaftor. | Drug: ABBV-576<br>* Oral<br>Drug: Navocaftor<br>* Oral<br>Drug: Midazolam<br>* Oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration (Cmax) | Cmax will be assessed. | Up to Day 52 | 
| Time to maximum observed plasma concentration (Tmax) | Tmax will be assessed. | Up to Day 52 | 
| Apparent terminal phase elimination rate constant (BETA or β) | Apparent terminal phase elimination rate constant (BETA or β) will be assessed. | Up to Day 52 | 
| Mean terminal phase elimination half-life (t1/2) | T1/2 will be assessed. | Up to Day 52 | 
| Area under the plasma curve (AUC) | AUC will be assessed. | Up to Day 52 | 
| 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 82 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Galicaftor, Navocaftor, ABBV-576, Cystic Fibrosis