Approval Probability
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Adjusted LOA
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SKY0402 in healthy patients · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| Low dose in healthy patients | EXPERIMENTAL | - |
| Low dose in hepatically impaired patients | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| SKY0402 300mg in healthy patients | DRUG | SKY0402, single administration of 300 mg via local infiltrations (subcutaneous) in healthy patients |
| SKY0402 300mg in hepatically impaired patients | DRUG | SKY0402, single administration of 300 mg via local infiltrations (subcutaneous) in hepatically impaired patients |
Inclusion Criteria: All Subjects: * Male or female, ages 18-65 years, inclusive, at Screening. Eligible female subjects of childbearing potential with a nonsterilized male sexual partner must agree to use a hormonal contraceptive, barrier contraceptive with additional spermicide, or an intrauterin...
SKY0402 in healthy patients refers to a Phase 1 clinical study of SKY0402, a small molecule being developed by Pacira BioSciences, Inc. for pain. The study evaluated the pharmacokinetics of SKY0402 in healthy adult subjects and in subjects with hepatic impairment. It enrolled 16 participants and has been completed.
SKY0402 is being developed for the treatment of pain. It is an investigational small molecule from Pacira BioSciences, Inc. that has been studied in a Phase 1 clinical trial. It has not been approved for any indication and remains in clinical development.
SKY0402 is being developed by Pacira BioSciences, Inc., which trades on the Nasdaq under the ticker PCRX. The company sponsored the Phase 1 hepatic impairment study of SKY0402 that was conducted in Poland.
SKY0402 is in Phase 1 clinical development. Its single recorded trial, NCT00812305, was a Phase 1 pharmacokinetic study in healthy and hepatically impaired subjects that has been completed. SKY0402 is investigational and has not been approved by the FDA.
SKY0402 has been studied in one clinical trial, NCT00812305, titled Hepatic Impairment Study: Pharmacokinetics in Healthy and Hepatically Impaired Subjects. The Phase 1 trial enrolled 16 participants in Poland, included healthy volunteers, and has been completed. No trials of SKY0402 are currently active.