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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-09

Study Completion Date

2024-09-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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ABBV-668 Regimen A

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

Group Type EXPERIMENTAL

ABBV-668 IR

Intervention Type DRUG

• Oral Capsule

ABBV-668 Regimen B

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

Group Type EXPERIMENTAL

ABBV-668 ER

Intervention Type DRUG

• Oral Tablets

ABBV-668 Regimen C

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

Group Type EXPERIMENTAL

ABBV-668 ER

Intervention Type DRUG

• Oral Tablets

ABBV-668 Regimen D

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

Group Type EXPERIMENTAL

ABBV-668 ER

Intervention Type DRUG

• Oral Tablets

ABBV-668 Regimen E

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

Group Type EXPERIMENTAL

ABBV-668 ER

Intervention Type DRUG

• Oral Tablets

ABBV-668 Regimen F

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

Group Type EXPERIMENTAL

ABBV-668 ER

Intervention Type DRUG

• Oral Tablets

ABBV-668 Regimen G

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

Group Type EXPERIMENTAL

ABBV-668 ER

Intervention Type DRUG

• Oral Tablets

Interventions

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ABBV-668 IR

• Oral Capsule

Intervention Type DRUG

ABBV-668 ER

• Oral Tablets

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes