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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: ABBV-668 ER; Drug: ABBV-668 IR

• Registration Number: NCT06477926
• Lead Sponsor: AbbVie

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-24
• Study First Submitted QC: 2024-06-24
• Study First Posted: 2024-06-27
• Study Start: 2024-07-09
• Primary Completion: 2024-09-20
• Study Completion: 2024-09-20
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-04
• Last Update Posted: 2024-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ABBV-668 Regimen D	ABBV-668 ER	Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 2 administered on day 1 under fasting conditions
ABBV-668 Regimen E	ABBV-668 ER	Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 2 administered on day 1 under fed conditions
ABBV-668 Regimen C	ABBV-668 ER	Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 1 administered on day 1 under fed conditions
ABBV-668 Regimen B	ABBV-668 ER	Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 1 administered on day 1 under fasting conditions
ABBV-668 Regimen A	ABBV-668 IR	Participants will receive ABBV-668 Immediate Release (IR) capsules on Day 1 under fasting conditions
ABBV-668 Regimen F	ABBV-668 ER	Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 3 administered on day 1 under fasting conditions
ABBV-668 Regimen G	ABBV-668 ER	Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 3 administered on day 1 under fed conditions

Primary Outcome Measures

Name	Time	Method
Terminal Phase Elimination Half-Life (t1/2) of ABBV-668	Up to approximately 47 days	Terminal phase elimination half-life of ABBV-668
Maximum Plasma Concentration (Cmax) of ABBV-668	Up to approximately 47 days	Cmax of ABBV-668
Time to Cmax (Tmax) of ABBV-668	Up to approximately 47 days	Tmax of ABBV-668
Terminal Phase Elimination Rate Constant (Beta) of ABBV-668	Up to approximately 47 days	Terminal phase elimination rate constant (beta) of ABBV-668
Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-668	Up to approximately 47 days	AUCt of ABBV-668
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-688	Up to approximately 47 days	AUCinf of ABBV-688
Number of Participants With Adverse Events (AEs)	Up to Day 47	An adverse event (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. The investigator assesses the relationship of each event to the use of study

Trial Locations

Locations (1)

Acpru /Id# 266960; 🇺🇸 Grayslake, Illinois, United States