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NCT07856706
A Single Ascending Dose, and Food Effect Study of ABBV-7828 in Healthy Adults
Conditions: Healthy Subjects
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 60
Sponsor: AbbVie
Location: Acpru /Id# 283545 Grayslake Illinois
Summary
This study is to evaluate safety, tolerability, pharmacokinetics and effect of food on ABBV-7828 compared to placebo in healthy adult participants.
Eligibility Criteria
Inclusion Criteria:
* Individuals between 18 to 65 years of age at the time of screening.
* BMI is \= 32.0 kg/m2.
* A condition of general good health, based upon the results of a medical history, physical evaluations, 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), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
* Has any clinically significant ECG abnormalities including the following:
* Evidence of 2nd or 3rd degree atrial ventricular (AV) block at screening visit or upon initial confinement
* QT interval corrected for heart rate (QTc) using Fridericia's correction formula (QTcF) \> 450 msec (males) or \> 460 msec (females) at screening visit or upon initial confinement.
* History of any clinically significant sensitivity or allergy to any medication or food.
* History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption.
Source: ClinicalTrials.gov (NCT07856706). StuddyBuddy aggregates publicly available trial information.