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ABBV-668 IR

Phase 1

Healthy Volunteers | Small molecule | Other |AbbVie Inc.|Last Updated: Oct 8, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

ABBV-668 IR · 1 trial · 1 indication

Phase 1 1
NCT06477926A Study to Assess Relative Bioavailability and Food Effect of ABBV-668 Extended-Release Formulations in Adult ParticipantsHealthy Volunteers
COMPLETED25 Analytics
PHASE1COMPLETED
A Study to Assess Relative Bioavailability and Food Effect of ABBV-668 Extended-Release Formulations in Adult Participants
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Study Endpoints

Primary Endpoints

Maximum Plasma Concentration (Cmax) of ABBV-668
Up to approximately 47 days

Cmax of ABBV-668

Time to Cmax (Tmax) of ABBV-668
Up to approximately 47 days

Tmax of ABBV-668

Terminal Phase Elimination Rate Constant (Beta) of ABBV-668
Up to approximately 47 days

Terminal phase elimination rate constant (beta) of ABBV-668

Terminal Phase Elimination Half-Life (t1/2) of ABBV-668
Up to approximately 47 days

Terminal phase elimination half-life of ABBV-668

Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-668
Up to approximately 47 days

AUCt of ABBV-668

Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-688
Up to approximately 47 days

AUCinf of ABBV-688

Number of Participants With Adverse Events (AEs)
Up to Day 47

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. The investigator assesses the relationship of each event to the use of study

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
ABBV-668 Regimen AEXPERIMENTALParticipants will receive ABBV-668 Immediate Release (IR) capsules on Day 1 under fasting conditions
ABBV-668 Regimen BEXPERIMENTALParticipants will receive ABBV-668 Extended Release (ER) tablets Formulation 1 administered on day 1 under fasting conditions
ABBV-668 Regimen CEXPERIMENTALParticipants will receive ABBV-668 Extended Release (ER) tablets Formulation 1 administered on day 1 under fed conditions
ABBV-668 Regimen DEXPERIMENTALParticipants will receive ABBV-668 Extended Release (ER) tablets Formulation 2 administered on day 1 under fasting conditions
ABBV-668 Regimen EEXPERIMENTALParticipants will receive ABBV-668 Extended Release (ER) tablets Formulation 2 administered on day 1 under fed conditions
ABBV-668 Regimen FEXPERIMENTALParticipants will receive ABBV-668 Extended Release (ER) tablets Formulation 3 administered on day 1 under fasting conditions
ABBV-668 Regimen GEXPERIMENTALParticipants will receive ABBV-668 Extended Release (ER) tablets Formulation 3 administered on day 1 under fed conditions

Interventions

NameTypeDescription
ABBV-668 IRDRUG• Oral Capsule
ABBV-668 ERDRUG• Oral Tablets
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * BMI is ≥ 18.0 to ≤ 32.0 kg/m\^2 after rounding to the tenths decimal at screening. * A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG. Exclusion Criteria: * History of any...

Countries:United States
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Frequently asked questions about ABBV-668 IR

What is ABBV-668 IR used for?

ABBV-668 IR is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial assessing its relative bioavailability and food effect. The drug is not approved and remains under investigation for its intended use.

Who makes ABBV-668 IR?

ABBV-668 IR is developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting clinical trials to evaluate the drug's properties in adult participants.

What phase is ABBV-668 IR in?

ABBV-668 IR is in Phase 1 clinical development. One Phase 1 trial has been completed, involving 25 healthy adult volunteers in the United States. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is ABBV-668 IR in?

ABBV-668 IR has one completed clinical trial, NCT06477926, titled 'A Study to Assess Relative Bioavailability and Food Effect of ABBV-668 Extended-Release Formulations in Adult Participants.' This Phase 1 study enrolled 25 healthy volunteers in the United States.

Is ABBV-668 IR the same as ABBV-668?

ABBV-668 IR is a formulation of the drug ABBV-668, with 'IR' indicating an immediate-release version. The completed trial also evaluated extended-release formulations of ABBV-668, comparing their bioavailability and food effects in healthy adults.