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SKY0402 in healthy patients

Phase 1

Pain | Small molecule | Gastrointestinal |Pacira BioSciences, Inc.|Last Updated: Sep 8, 2010

Target and mechanism

ModalitySmall molecule

Also known as SKY0402 300mg in healthy patients

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

SKY0402 in healthy patients · 1 trial · 2 indications

Phase 1 1
NCT00812305Hepatic Impairment Study: Pharmacokinetics in Healthy and Hepatically Impaired SubjectsPain
COMPLETED16 Analytics
PHASE1COMPLETED
Hepatic Impairment Study: Pharmacokinetics in Healthy and Hepatically Impaired Subjects
Pain
NCT0081230516
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Study Endpoints

Primary Endpoints

Serum plasma concentration of SKY0402
Multiple through 96 hours
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Low dose in healthy patientsEXPERIMENTAL -
Low dose in hepatically impaired patientsEXPERIMENTAL -

Interventions

NameTypeDescription
SKY0402 300mg in healthy patientsDRUGSKY0402, single administration of 300 mg via local infiltrations (subcutaneous) in healthy patients
SKY0402 300mg in hepatically impaired patientsDRUGSKY0402, single administration of 300 mg via local infiltrations (subcutaneous) in hepatically impaired patients
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:Poland
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