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

AbbVie

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: ABBV-903 Tablet Form 2; Drug: ABBV-903 Tablet Form 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT05836506

M24-226

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

Part 1: Sequence A

Experimental group

Description:

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.

Treatment:

Drug: ABBV-903 Tablet Form 2

Drug: ABBV-903 Tablet Form 1

Part 1: Sequence B

Experimental group

Description:

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.

Treatment:

Drug: ABBV-903 Tablet Form 2

Drug: ABBV-903 Tablet Form 1

Part 2: Sequence A

Experimental group

Description:

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.

Treatment:

Drug: ABBV-903 Tablet Form 2

Drug: ABBV-903 Tablet Form 1

Part 2: Sequence B

Experimental group

Description:

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.

Treatment:

Drug: ABBV-903 Tablet Form 2

Drug: ABBV-903 Tablet Form 1