A Study to Assess Relative Bioavailability and Food Effect of ABBV-668 Extended-Release Formulations in Adult Participants

AbbVie

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: ABBV-668 ER; Drug: ABBV-668 IR

Study type: Interventional

Funder types: Industry

Identifiers

NCT06477926

M25-176

Details and patient eligibility

About

The objectives of this study are to assess safety and tolerability of the new ABBV-668 ER tablets, to assess the oral bioavailability of the ABBV-668 ER tablets relative to the ABBV-668 IR capsules, and to assess the pharmacokinetics of the ER tablets under fasting and fed conditions in healthy adults.

Enrollment: 25 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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 clinically significant sensitivity or allergy to any medication or food.
• History of any investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug or is currently enrolled in another clinical study or was previously enrolled in this study.
• History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
• Participant using any medication, vitamins and/or herbal supplements (including traditional Chinese medicine), with the exception of hormonal replacement therapies for females, on a regular basis.
• Any use of tobacco or nicotine-containing products within 180 days prior to the first dose of study drug.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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25 participants in 7 patient groups

ABBV-668 Regimen A

Experimental group

Description:

Participants will receive ABBV-668 Immediate Release (IR) capsules on Day 1 under fasting conditions

Treatment:

Drug: ABBV-668 IR

ABBV-668 Regimen B

Experimental group

Description:

Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 1 administered on day 1 under fasting conditions

Treatment:

Drug: ABBV-668 ER

ABBV-668 Regimen C

Experimental group

Description:

Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 1 administered on day 1 under fed conditions

Treatment:

Drug: ABBV-668 ER

ABBV-668 Regimen D

Experimental group

Description:

Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 2 administered on day 1 under fasting conditions

Treatment:

Drug: ABBV-668 ER

ABBV-668 Regimen E

Experimental group

Description:

Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 2 administered on day 1 under fed conditions

Treatment:

Drug: ABBV-668 ER

ABBV-668 Regimen F

Experimental group

Description:

Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 3 administered on day 1 under fasting conditions

Treatment:

Drug: ABBV-668 ER

ABBV-668 Regimen G

Experimental group

Description:

Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 3 administered on day 1 under fed conditions

Treatment:

Drug: ABBV-668 ER