A Study to Assess Relative Bioavailability and Food Effect of ABBV-668 Extended-Release Formulations in Adult Participants
Completed · Phase 1
Conditions studied: Healthy Volunteers
In brief
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.
Key facts
- Study ID
- NCT06477926
- Run by
- AbbVie
- People needed
- 25
- Starts
- 2024-07-09
- Expected to finish
- 2024-09-20
- Last updated by the study team
- 2024-10-08
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
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.
Where it is running
- Acpru /Id# 266960 — Grayslake, Illinois, United States
Full record on ClinicalTrials.gov
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