A Study to Assess the Relative Bioavailability of Immediate Release Formulations of ABBV-903 in Healthy 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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-18

Study Completion Date

2023-06-20

Brief Summary

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The main objective of this study is to assess the relative bioavailability and pharmacokinetics of ABBV-903 in healthy adult participants.

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Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1: Sequence A

In 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.

Group Type EXPERIMENTAL

ABBV-903 Tablet Form 1

Intervention Type DRUG

Oral Tablets

ABBV-903 Tablet Form 2

Intervention Type DRUG

Oral Tablets

Part 1: Sequence B

In 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.

Group Type EXPERIMENTAL

ABBV-903 Tablet Form 1

Intervention Type DRUG

Oral Tablets

ABBV-903 Tablet Form 2

Intervention Type DRUG

Oral Tablets

Part 2: Sequence A

In 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.

Group Type EXPERIMENTAL

ABBV-903 Tablet Form 1

Intervention Type DRUG

Oral Tablets

ABBV-903 Tablet Form 2

Intervention Type DRUG

Oral Tablets

Part 2: Sequence B

In 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.

Group Type EXPERIMENTAL

ABBV-903 Tablet Form 1

Intervention Type DRUG

Oral Tablets

ABBV-903 Tablet Form 2

Intervention Type DRUG

Oral Tablets

Interventions

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ABBV-903 Tablet Form 1

Oral Tablets

Intervention Type DRUG

ABBV-903 Tablet Form 2

Oral Tablets

Intervention Type DRUG

Eligibility Criteria

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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, laboratory profile and a 12-lead ECG.

Exclusion Criteria

* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
* History of diseases aggravated or triggered by ultraviolet radiation and no history of abnormal reaction photosensitivity or photoallergy to sunlight, or artificial source of intense light, especially ultraviolet light.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes