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ABBV-903 Form 1

Phase 1

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

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 being developed by AbbVie Inc. It is currently in Phase 1 clinical development. The drug is being studied in healthy volunteers to assess the relative bioavailability of immediate release formulations of ABBV-903.

What is ABBV-903 Form 1 used for?

ABBV-903 Form 1 is being studied for use in healthy volunteers. The purpose of the clinical trial is to assess the relative bioavailability of immediate release formulations of ABBV-903 in healthy adult participants. It is not yet approved for any medical condition.

Who makes ABBV-903 Form 1?

ABBV-903 Form 1 is being developed by AbbVie Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug's bioavailability in healthy volunteers. AbbVie's stock ticker is ABBV.

What phase is ABBV-903 Form 1 in?

ABBV-903 Form 1 is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. It is currently being studied in a completed Phase 1 trial involving healthy adult participants.

What clinical trials is ABBV-903 Form 1 in?

ABBV-903 Form 1 is associated with clinical trial NCT05836506, titled 'A Study to Assess the Relative Bioavailability of Immediate Release Formulations of ABBV-903 in Healthy Adult Participants.' This Phase 1 trial was conducted in the United States and has been completed.

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

ABBV-903 Form 1 is a specific formulation of ABBV-903. The clinical trial NCT05836506 evaluates immediate release formulations of ABBV-903, including Form 1, to compare their relative bioavailability. The drug is being developed by AbbVie Inc.