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
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy-volunteers
Started Jul 2024
Shorter than P25 for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2024
CompletedFirst Posted
Study publicly available on registry
June 27, 2024
CompletedStudy Start
First participant enrolled
July 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2024
CompletedOctober 8, 2024
October 1, 2024
2 months
June 24, 2024
October 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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
Study Arms (7)
ABBV-668 Regimen A
EXPERIMENTALParticipants will receive ABBV-668 Immediate Release (IR) capsules on Day 1 under fasting conditions
ABBV-668 Regimen B
EXPERIMENTALParticipants will receive ABBV-668 Extended Release (ER) tablets Formulation 1 administered on day 1 under fasting conditions
ABBV-668 Regimen C
EXPERIMENTALParticipants will receive ABBV-668 Extended Release (ER) tablets Formulation 1 administered on day 1 under fed conditions
ABBV-668 Regimen D
EXPERIMENTALParticipants will receive ABBV-668 Extended Release (ER) tablets Formulation 2 administered on day 1 under fasting conditions
ABBV-668 Regimen E
EXPERIMENTALParticipants will receive ABBV-668 Extended Release (ER) tablets Formulation 2 administered on day 1 under fed conditions
ABBV-668 Regimen F
EXPERIMENTALParticipants will receive ABBV-668 Extended Release (ER) tablets Formulation 3 administered on day 1 under fasting conditions
ABBV-668 Regimen G
EXPERIMENTALParticipants will receive ABBV-668 Extended Release (ER) tablets Formulation 3 administered on day 1 under fed conditions
Interventions
• Oral Tablets
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (1)
Acpru /Id# 266960
Grayslake, Illinois, 60030, United States
Related Links
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2024
First Posted
June 27, 2024
Study Start
July 9, 2024
Primary Completion
September 20, 2024
Study Completion
September 20, 2024
Last Updated
October 8, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share