Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Fosigotifator, FGT
ABBV-CLS-7262 · 3 trials · 1 indication
Area under the Curve (AUC)
Area under the Curve (AUC)
To evaluate the effect of ABBV-CLS-7262 on the QTc interval in healthy adult subjects.
Maximum Plasma Concentration \[Cmax\]; Area under the Curve (AUC)
Maximum Plasma Concentration \[Cmax\]; Area under the Curve (AUC)
| Arm | Type | Description |
|---|---|---|
| ABBV-CLS-7262 | EXPERIMENTAL | ABBV-CLS-7262 + Digoxin + Rosuvastatin |
| Sequence 1 | EXPERIMENTAL | Subjects will receive ABBV-CLS-7262 dose 1, ABBV-CLS-7262 dose 2, placebo, or moxifloxacin 400 mg tablet |
| Sequence 2 | EXPERIMENTAL | Subjects will receive ABBV-CLS-7262 dose 1, ABBV-CLS-7262 dose 2, placebo, or moxifloxacin 400 mg tablet |
| Sequence 3 | EXPERIMENTAL | Subjects will receive ABBV-CLS-7262 dose 1, ABBV-CLS-7262 dose 2, placebo, or moxifloxacin 400 mg tablet |
| Sequence 4 | EXPERIMENTAL | Subjects will receive ABBV-CLS-7262 dose 1, ABBV-CLS-7262 dose 2, placebo, or moxifloxacin 400 mg tablet |
| Period 1, 2 and 3 ABBV-CLS-7262 | EXPERIMENTAL | * Participants will receive ABBV-CLS-7262 administered under fasted conditions. * Participants will receive ABBV-CLS-7262 administered under fed conditions (high-fat/high-calorie breakfast). * Participants will receive ABBV-CLS-7262 administered with applesauce. |
| Name | Type | Description |
|---|---|---|
| ABBV-CLS-7262 | DRUG | Drug: ABBV-CLS-7262 Drug: Digoxin Drug: Rosuvastatin |
| Placebo | DRUG | • single oral dose |
| Moxifloxacin 400mg | DRUG | • single oral dose |
Inclusion Criteria: * Adult volunteers in general good health * Must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures * Individuals between 18 and ...
ABBV-CLS-7262 is an investigational small molecule developed by AbbVie Inc. It has been studied in Phase 1 clinical trials conducted in healthy adult volunteers in the United States. The program includes three completed Phase 1 studies with a combined enrollment of 102 participants.
ABBV-CLS-7262 is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the clinical program evaluating this small molecule in Phase 1 studies.
ABBV-CLS-7262 is in Phase 1 clinical development. All three of its registered trials are Phase 1 studies, and all three are listed as completed. There are currently no active trials for this asset, and it is an investigational compound rather than an approved medicine.
Three completed Phase 1 trials are registered for ABBV-CLS-7262: NCT06310876, a thorough QT study in 72 healthy subjects; NCT06145607, a food effect pharmacokinetics study in 18 healthy subjects; and NCT05763459, a study with rosuvastatin and digoxin in 12 healthy subjects. All were conducted in the United States.
The ABBV-CLS-7262 Phase 1 program enrolled 102 healthy adult volunteers across three completed studies. The trials were randomized, double blind, and controlled. They assessed cardiac repolarization, the effect of food on pharmacokinetics, and drug interaction potential with rosuvastatin and digoxin.