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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixed Sequence | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dextromethorphan HBr | Drug | A single 60 mg dose of DM capsules liquid-filled on Day 1 and Day 3 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) profile for dextromethorphan (DM) (in plasma): AUC0-t | 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 | 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 | 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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Inclusion Criteria:
Male or female, non-smoker, ≥ 18 and ≤ 55 years of age, with BMI > 18.5 and < 30.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.
Healthy as defined by:
Females of childbearing potential must be willing to use acceptable contraceptive method throughout the study and for 30 days after the last study drug administration:
Male subjects must be willing to use acceptable contraceptive method from the first dosing until at least 90 days after the last study drug administration:
Male subjects (including men who have had vasectomies) with a pregnant partner must agree to use a condom from the first dosing until at least 90 days after the last study drug administration.
Male subjects must be willing not to donate sperm until 90 days following the last study drug administration.
Capable of consent.
Consent to perform genotyping for CYP2D6.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inventiv Health Clinical - Research Pharmacy Unit | Miami | Florida | 33136 | United States |
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| GC4419 | Drug | Daily 90 mg IV infusions over 60 minutes on Day 3 and Day 4 |
|
| ID | Term |
|---|---|
| D003915 | Dextromethorphan |
| C000707700 | avasopasem manganese |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
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