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ABBV-903 Form 1

Phase 1

Healthy Volunteer | Small molecule | Other |AbbVie Inc.|Last Updated: Jul 17, 2023

Target and mechanism

ModalitySmall molecule

Also known as ABBV-903 Tablet Form 1

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

ABBV-903 Form 1 · 1 trial · 1 indication

Phase 1 1
NCT05836506A Study to Assess the Relative Bioavailability of Immediate Release Formulations of ABBV-903 in Healthy Adult ParticipantsHealthy Volunteer
COMPLETED24 Analytics
PHASE1COMPLETED
A Study to Assess the Relative Bioavailability of Immediate Release Formulations of ABBV-903 in Healthy Adult Participants
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Study Endpoints

Primary Endpoints

Number of Participants with Adverse Events (AEs)
Up to Approximately 44 days

An 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

Maximum Plasma Concentration (Cmax) of ABBV-903
Up to approximately 14 days

Cmax of ABBV-903

Time to Cmax (Tmax) of ABBV-903
Up to approximately 14 days

Tmax of ABBV-903

Terminal Phase Elimination Half-Life (t1/2) of ABBV-903
Up to approximately 14 days

Terminal phase elimination half-life of ABBV-903

Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-903
Up to approximately 14 days

AUCt of ABBV-903

Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-903
Up to approximately 14 days

AUCinf of ABBV-903

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1: Sequence AEXPERIMENTALIn Period 1 on Day 1, participants will receive ABBV-903 Tablet Form 1 after fasting. In Period 2 on Day 1, participants will receive ABBV-903 Tablet Form 2 after fasting. Lastly, in Period 3 on Day 1, participants will receive ABBV-903 Tablet Form 1 after a high fat meal. Participants will be followed up for 30 days.
Part 1: Sequence BEXPERIMENTALIn Period 1 on Day 1, participants will receive ABBV-903 Tablet Form 2 after fasting. In Period 2 on Day 1, participants will receive ABBV-903 Tablet Form 1 after fasting. Lastly, in Period 3 on Day 1, participants will receive ABBV-903 Tablet Form 1 after fasting. Participants will be followed up for 30 days.
Part 2: Sequence AEXPERIMENTALIn Period 1 on Day 1, participants will receive ABBV-903 Tablet Form 1 after fasting. In Period 2 on Day 1, participants will receive ABBV-903 Tablet Form 2 after fasting. Lastly, in Period 3 on Day 1, participants will receive ABBV-903 Tablet Form 2 after a high fat meal. Participants will be followed up for 30 days.
Part 2: Sequence BEXPERIMENTALIn Period 1 on Day 1, participants will receive ABBV-903 Tablet Form 2 after fasting. In Period 2 on Day 1, participants will receive ABBV-903 Tablet Form 1 after fasting. Lastly, in Period 3 on Day 1, participants will receive ABBV-903 Tablet Form 2 after fasting. Participants will be followed up for 30 days.

Interventions

NameTypeDescription
ABBV-903 Tablet Form 1DRUGOral Tablets
ABBV-903 Tablet Form 2DRUGOral Tablets
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * BMI is ≥ 18.0 to ≤ 32 kg/m2 after rounding to the tenth. * Negative test result for SARS-CoV-2 infection at screening visit and upon initial confinement. * A condition of general good health, based upon the results of a medical history, physical examination, vital signs, labor...

Countries:United States
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Frequently asked questions about ABBV-903 Form 1

What is ABBV-903 Form 1?

ABBV-903 Form 1 is an investigational small molecule drug candidate developed by AbbVie Inc. It is an immediate release oral formulation that has been studied in healthy adult volunteers. It is not approved for any indication and remains in early clinical development.

What is ABBV-903 Form 1 used for?

ABBV-903 Form 1 has been studied in healthy adult volunteers, not in patients with a specific disease. The single completed trial evaluated the relative bioavailability of immediate release formulations of ABBV-903 in healthy participants. No therapeutic indication has been established for this formulation.

Who makes ABBV-903 Form 1?

ABBV-903 Form 1 is developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie sponsored the Phase 1 bioavailability study of the immediate release formulations conducted in the United States.

What phase is ABBV-903 Form 1 in?

ABBV-903 Form 1 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is ABBV-903 Form 1 in?

ABBV-903 Form 1 has been evaluated in one completed Phase 1 trial, NCT05836506, titled A Study to Assess the Relative Bioavailability of Immediate Release Formulations of ABBV-903 in Healthy Adult Participants. The randomized, controlled study enrolled 24 healthy adults aged 18 years and older in the United States.

Is ABBV-903 Form 1 the same as ABBV-903 Tablet Form 1?

Yes, ABBV-903 Form 1 is also known as ABBV-903 Tablet Form 1. Both names refer to the same immediate release oral formulation of ABBV-903 developed by AbbVie Inc. that was studied in the Phase 1 bioavailability trial NCT05836506.