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

A Phase 1 Relative Bioavailability and Food Effect Study of ABBV-668 Extended-Release Formulations

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: ABBV-668 IR; Drug: ABBV-668 ER

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Grayslake, Illinois, United States, 60030
      • Acpru /Id# 266960

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABBV-668 Regimen A; Participants will receive ABBV-668 Immediate Release (IR) capsules on Day 1 under fasting conditions	Drug: ABBV-668 IR; • Oral Capsule
Experimental: ABBV-668 Regimen B; Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 1 administered on day 1 under fasting conditions	Drug: ABBV-668 ER; • Oral Tablets
Experimental: ABBV-668 Regimen C; Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 1 administered on day 1 under fed conditions	Drug: ABBV-668 ER; • Oral Tablets
Experimental: ABBV-668 Regimen D; Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 2 administered on day 1 under fasting conditions	Drug: ABBV-668 ER; • Oral Tablets
Experimental: ABBV-668 Regimen E; Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 2 administered on day 1 under fed conditions	Drug: ABBV-668 ER; • Oral Tablets
Experimental: ABBV-668 Regimen F; Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 3 administered on day 1 under fasting conditions	Drug: ABBV-668 ER; • Oral Tablets
Experimental: ABBV-668 Regimen G; Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 3 administered on day 1 under fed conditions	Drug: ABBV-668 ER; • Oral Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Plasma Concentration (Cmax) of ABBV-668	Cmax of ABBV-668	Up to approximately 47 days
Time to Cmax (Tmax) of ABBV-668	Tmax of ABBV-668	Up to approximately 47 days
Terminal Phase Elimination Rate Constant (Beta) of ABBV-668	Terminal phase elimination rate constant (beta) of ABBV-668	Up to approximately 47 days
Terminal Phase Elimination Half-Life (t1/2) of ABBV-668	Terminal phase elimination half-life of ABBV-668	Up to approximately 47 days
Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-668	AUCt of ABBV-668	Up to approximately 47 days
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-688	AUCinf of ABBV-688	Up to approximately 47 days
Number of Participants With Adverse Events (AEs)	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	Up to Day 47

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2024
• Primary Completion (Actual): September 20, 2024
• Study Completion (Actual): September 20, 2024

Study Registration Dates

• First Submitted: June 24, 2024
• First Submitted That Met QC Criteria: June 24, 2024
• First Posted (Actual): June 27, 2024

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 4, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Healthy Volunteers; ABBV-668
• Other Study ID Numbers: M25-176

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No