This study is a randomized, three period, six sequence, single dose crossover design with ABBV-CLS-7262 in healthy adult subjects.
On Day 1 of each period, subjects will receive a single oral dose of ABBV-CLS-7262 administered according to the food regimen assigned. There will be a 4-day washout period between doses. Food regimens include administration after fasting, following a high-fat/high-calorie meal, or with apple sauce. Upon completion each subject will have taken a total of three doses of ABBV-CLS-7262, with one dose administered with each food regimen.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
ABBV-CLS-7262
AbbVie Clinical Pharmacology Research Unit (ACPRU)
Grayslake, Illinois, United States
To assess the pharmacokinetics following a single oral dose of ABBV-CLS-7262 taken with or without food.
Maximum Plasma Concentration \[Cmax\]; Area under the Curve (AUC)
Time frame: Approximately Two Weeks
To assess the pharmacokinetics following a single oral dose of ABBV-CLS-7262 administered with or without applesauce.
Maximum Plasma Concentration \[Cmax\]; Area under the Curve (AUC)
Time frame: Approximately Two Weeks
Safety and Tolerability
Number of patients with treatment-related adverse events as assessed by NCI CTCAE v4.03
Time frame: Approximately Six Weeks
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