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ABBV-CLS-7262

Phase 1

Healthy | Small molecule | Other |AbbVie Inc.|Last Updated: Jul 1, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials3
Total Enrollment102

FDA Designations

No designations recorded

Clinical trial landscape

ABBV-CLS-7262 · 3 trials · 1 indication

Phase 1 3
NCT05763459A Phase 1 Study of ABBV-CLS-7262, Rosuvastatin, and Digoxin in Healthy SubjectsHealthy
COMPLETED12 Analytics
NCT06310876A Thorough QT Study of ABBV-CLS-7262 in Healthy SubjectsHealthy
COMPLETED72 Analytics
NCT06145607A Phase 1 Study Assessing the Effect of Food on the Pharmacokinetics of ABBV- CLS-7262Healthy
COMPLETED18 Analytics
PHASE1COMPLETED
A Phase 1 Study of ABBV-CLS-7262, Rosuvastatin, and Digoxin in Healthy Subjects
HealthyUnlock trial analytics
PHASE1COMPLETED
A Thorough QT Study of ABBV-CLS-7262 in Healthy Subjects
HealthyUnlock trial analytics
PHASE1COMPLETED
A Phase 1 Study Assessing the Effect of Food on the Pharmacokinetics of ABBV- CLS-7262
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Pharmacokinetics of Rosuvastatin
Two Weeks

Area under the Curve (AUC)

Pharmacokinetics of Digoxin
Two Weeks

Area under the Curve (AUC)

To evaluate the effect of ABBV-CLS-7262 on the QTc interval in healthy adult subjects
Up to 24 hours

To evaluate the effect of ABBV-CLS-7262 on the QTc interval in healthy adult subjects.

To assess the pharmacokinetics following a single oral dose of ABBV-CLS-7262 taken with or without food.
Approximately Two Weeks

Maximum Plasma Concentration \[Cmax\]; Area under the Curve (AUC)

To assess the pharmacokinetics following a single oral dose of ABBV-CLS-7262 administered with or without applesauce.
Approximately Two Weeks

Maximum Plasma Concentration \[Cmax\]; Area under the Curve (AUC)

Secondary Endpoints

Safety and Tolerability
Two Weeks
To evaluate the effects of ABBV-CLS-7262 on change in electrocardiogram (ECG) parameters
Up to 24 hours
To evaluate the sensitivity of QTc measurement using moxifloxacin
Up to 24 hours
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ABBV-CLS-7262EXPERIMENTALABBV-CLS-7262 + Digoxin + Rosuvastatin
Sequence 1EXPERIMENTALSubjects will receive ABBV-CLS-7262 dose 1, ABBV-CLS-7262 dose 2, placebo, or moxifloxacin 400 mg tablet
Sequence 2EXPERIMENTALSubjects will receive ABBV-CLS-7262 dose 1, ABBV-CLS-7262 dose 2, placebo, or moxifloxacin 400 mg tablet
Sequence 3EXPERIMENTALSubjects will receive ABBV-CLS-7262 dose 1, ABBV-CLS-7262 dose 2, placebo, or moxifloxacin 400 mg tablet
Sequence 4EXPERIMENTALSubjects 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-7262EXPERIMENTAL* 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.

Interventions

NameTypeDescription
ABBV-CLS-7262DRUGDrug: ABBV-CLS-7262 Drug: Digoxin Drug: Rosuvastatin
PlaceboDRUG• single oral dose
Moxifloxacin 400mgDRUG• single oral dose
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 ...

Countries:United States
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Frequently asked questions about ABBV-CLS-7262

What is ABBV-CLS-7262?

ABBV-CLS-7262 is an investigational small molecule being developed by AbbVie Inc. (ABBV). It is currently in Phase 1 clinical development, with studies conducted in healthy volunteers. The drug is being evaluated in early-stage trials to assess its safety, tolerability, and pharmacokinetics.

What is ABBV-CLS-7262 used for?

ABBV-CLS-7262 is being studied in healthy volunteers as part of Phase 1 clinical trials. These studies are designed to evaluate the drug's safety, tolerability, and how it is processed by the body. The specific therapeutic indication has not been disclosed in the available trial information.

Who makes ABBV-CLS-7262?

ABBV-CLS-7262 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. AbbVie is conducting Phase 1 clinical trials of this investigational small molecule in healthy subjects.

What phase is ABBV-CLS-7262 in?

ABBV-CLS-7262 is in Phase 1 clinical development. All three completed trials for this drug were Phase 1 studies conducted in healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is ABBV-CLS-7262 in?

ABBV-CLS-7262 has been studied in three completed Phase 1 trials: NCT05763459, a drug interaction study with rosuvastatin and digoxin; NCT06145607, a food effect study; and NCT06310876, a thorough QT study. All trials enrolled healthy adults in the United States.

Is ABBV-CLS-7262 the same as any other drug?

ABBV-CLS-7262 is the code name used by AbbVie for this investigational compound. No alternative names have been disclosed in the available clinical trial information. The drug is identified solely by this designation in the registered trials.