Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being studied in healthy volunteers. It is being evaluated as part of combination regimens for the treatment of cystic fibrosis, though it has not been approved for any indication. The drug is currently in Phase 1 clinical development.
Galicaftor is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting Phase 1 clinical trials to assess the drug's safety and pharmacokinetics.
Galicaftor is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, both enrolling healthy volunteers to evaluate the drug's safety and how it is processed by the body.
Galicaftor has been studied in two completed Phase 1 trials. NCT05530278 assessed the pharmacokinetics and safety of co-administered oral Galicaftor, Navocaftor, and ABBV-576 in healthy adults. NCT05538585 evaluated how food affects the safety and pharmacokinetics of Galicaftor and Navocaftor. Both trials enrolled 24 participants each in the United States.
No, Galicaftor is not the same as Navocaftor. They are separate investigational drugs that have been studied together in combination. In clinical trials, they have been co-administered to assess their combined safety and pharmacokinetic profiles in healthy volunteers.