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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABBV-576 with Galicaftor + Navocaftor | Experimental | Participants will receive ABBV-576 for 14 consecutive days, with navocaftor + galicaftor for the latter 7 consecutive days. |
|
| Navocaftor + Galicaftor with ABBV 576 | Experimental | Participants will receive Navocaftor + galicaftor for 14 consecutive days, with ABBV 576 for the latter 7 consecutive days. |
|
| Optional: Navocaftor with ABBV 576 | Experimental | Participants will receive Navocaftor for 14 consecutive days with ABBV 576 for the latter 7 consecutive days. |
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| Optional: Galicaftor with ABBV 576 | Experimental | Participants will receive Galicaftor for 14 consecutive days, with ABBV 576 for the latter 7 consecutive days. |
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| Optional: Midazolam with ABBV-576 + Navocaftor | Experimental | Participants will receive Midazolam alone and in combination with multiple doses of ABBV-576 + navocaftor. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Galicaftor | Drug | Oral |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials LLC /ID# 248824 | Anaheim | California | 92801-2658 | United States | ||
| Clinical Pharmacology of Miami /ID# 248823 |
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|
| ABBV-576 | Drug | Oral |
|
| Navocaftor | Drug | Oral |
|
| Midazolam | Drug | Oral |
|
| Miami |
| Florida |
| 33014 |
| United States |
| PPD Clinical Research Unit -Las Vegas /ID# 248853 | Las Vegas | Nevada | 89113-2235 | United States |
| PPD Clinical Research Unit - Austin /ID# 248854 | Austin | Texas | 78744 | United States |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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