Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ABBV-2222
Galicaftor · 2 trials · 1 indication
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...
Galicaftor is an investigational small molecule developed by AbbVie Inc. (ticker ABBV) as a positive modulator of CFTR, the cystic fibrosis transmembrane conductance regulator protein. It is being studied in Phase 1 clinical trials, including studies in healthy adult volunteers.
Galicaftor targets CFTR, the cystic fibrosis transmembrane conductance regulator. It is classified as a positive modulator, meaning it is designed to enhance CFTR function. This mechanism is relevant to cystic fibrosis, though the specific indications for Galicaftor are not disclosed.
Galicaftor is being developed by AbbVie Inc., which trades under the ticker ABBV. AbbVie is the sponsor of the clinical trials evaluating Galicaftor, including Phase 1 studies in healthy volunteers.
Galicaftor is in Phase 1 clinical development. It has completed two Phase 1 trials with a total enrollment of 48 participants. It is investigational and has not been approved by the FDA for any indication.
Galicaftor has been evaluated in two completed Phase 1 trials. NCT05538585 assessed how food affects the safety and pharmacokinetics of Galicaftor and Navocaftor in 24 healthy volunteers. NCT05530278 assessed pharmacokinetics and safety of co-administered Galicaftor, Navocaftor, and ABBV-576 in 24 healthy female adults.