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

Sponsor

AbbVie (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05836506

Collaborator

(none)

Enrollment

Location

Arms

1.8

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteer	Drug: ABBV-903 Tablet Form 1 Drug: ABBV-903 Tablet Form 2	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Assessment of the Relative Bioavailability of Immediate Release Formulations of ABBV-903 in Healthy Volunteers

Anticipated Study Start Date :

Apr 24, 2023

Anticipated Primary Completion Date :

Jun 19, 2023

Anticipated Study Completion Date :

Jun 19, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: ABBV-903 Tablet Form 1 Oral Tablets Drug: ABBV-903 Tablet Form 2 Oral Tablets
Experimental: 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.	Drug: ABBV-903 Tablet Form 1 Oral Tablets Drug: ABBV-903 Tablet Form 2 Oral Tablets
Experimental: 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.	Drug: ABBV-903 Tablet Form 1 Oral Tablets Drug: ABBV-903 Tablet Form 2 Oral Tablets
Experimental: 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.	Drug: ABBV-903 Tablet Form 1 Oral Tablets Drug: ABBV-903 Tablet Form 2 Oral Tablets

Outcome Measures

Primary Outcome Measures

Number of Participants with Adverse Events (AEs) [Up to Approximately 44 days]
An 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
Maximum Plasma Concentration (Cmax) of ABBV-903 [Up to approximately 14 days]
Cmax of ABBV-903
Time to Cmax (Tmax) of ABBV-903 [Up to approximately 14 days]
Tmax of ABBV-903
Terminal Phase Elimination Half-Life (t1/2) of ABBV-903 [Up to approximately 14 days]
Terminal phase elimination half-life of ABBV-903
Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-903 [Up to approximately 14 days]
AUCt of ABBV-903
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-903 [Up to approximately 14 days]
AUCinf of ABBV-903

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Acpru /Id# 254926	Grayslake	Illinois	United States	60030

Sponsors and Collaborators

AbbVie

Investigators

Study Director: ABBVIE INC., AbbVie

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Info

Publications

None provided.

Responsible Party:

AbbVie

ClinicalTrials.gov Identifier:

NCT05836506

Other Study ID Numbers:

M24-226

First Posted:

May 1, 2023

Last Update Posted:

May 1, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by AbbVie

ABBV-903

Healthy Volunteer

Study Results

No Results Posted as of May 1, 2023