Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05538585 | A Study to Assess How Food Affects the Safety and Pharmacokinetics of Galicaftor and Navocaftor | PHASE1 | COMPLETED | 24 | — | — | Sep 27, 2022 | Dec 21, 2022 | Jan 17, 2023 | 2 | United States |
| NCT05530278 | 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 | PHASE1 | COMPLETED | 24 | — | — | Sep 20, 2022 | Nov 29, 2022 | Feb 21, 2023 | 4 | United States |
Cmax will be assessed.
Tmax will be assessed.
Terminal elimination half-life (t1/2) will be assessed.
AUC will be assessed.
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.
Cmax will be assessed.
Tmax will be assessed.
Apparent terminal phase elimination rate constant (BETA or β) will be assessed.
T1/2 will be assessed.
| Arm | Type | Description |
|---|---|---|
| Part 1: Navocaftor with food | EXPERIMENTAL | Participants will receive navocaftor administered with food |
| Part 1: Navocaftor without food | EXPERIMENTAL | Participants will receive navocaftor administered without food |
| Part 2: Galicaftor with food | EXPERIMENTAL | Participants will receive galicaftor administered with food |
| Part 2: Galicaftor without food | EXPERIMENTAL | Participants will receive galicaftor administered without food |
| 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. |
| Optional: Galicaftor with ABBV 576 | EXPERIMENTAL | Participants will receive Galicaftor for 14 consecutive days, with ABBV 576 for the latter 7 consecutive days. |
| 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 |
|---|---|---|
| Galicaftor | DRUG | Oral |
| Navocaftor | DRUG | Oral |
| ABBV-576 | DRUG | Oral |
| Midazolam | DRUG | Oral |
Inclusion Criteria: * Body Mass Index (BMI) is =\> 18.0 to \<= 32.0 kg/ m2 after rounding to the tenth's 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). Exclusio...