This will be a single center, phase 1, open-label, fixed-sequence study under fasting conditions to evaluate the effect of 90 mg intravenous (IV) infusions of GC4419 on the single-dose pharmacokinetic (PK) of dextromethorphan (DM) capsules liquid filled.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
A single 60 mg dose of DM capsules liquid-filled on Day 1 and Day 3
Daily 90 mg IV infusions over 60 minutes on Day 3 and Day 4
Inventiv Health Clinical - Research Pharmacy Unit
Miami, Florida, United States
Pharmacokinetic (PK) profile for dextromethorphan (DM) (in plasma): AUC0-t
Time frame: Pre-dose on Day 1, and at 0.5, 1 (immediately prior to the end of GC4419 infusion), 2, 3, 4, 6, 8, 12, and 24 hours after the start of infusion
Pharmacokinetic (PK) profile for dextromethorphan (DM) (in plasma): AUC0-inf
Time frame: Pre-dose on Day 1, and at 0.5, 1 (immediately prior to the end of GC4419 infusion), 2, 3, 4, 6, 8, 12, and 24 hours after the start of infusion
Pharmacokinetic (PK) profile for dextromethorphan (DM) (in plasma): Cmax
Time frame: Pre-dose on Day 1, and at 0.5, 1 (immediately prior to the end of GC4419 infusion), 2, 3, 4, 6, 8, 12, and 24 hours after the start of infusion
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