Pharmacokinetic Study of SP-103 in Healthy Adult Human Subjects
NCT ID: NCT04819581
Last Updated: 2021-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
15 participants
INTERVENTIONAL
2019-08-03
2019-08-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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SP-103 (1 topical system)
One topical system applied to the skin on the back for 12 hours.
SP-103
lidocaine topical system 5.4%
SP-103 (2 topical systems)
Two topical systems applied to the skin on the back for 12 hours.
SP-103
lidocaine topical system 5.4%
SP-103 (3 topical systems)
Three topical systems applied to the skin on the back for 12 hours.
SP-103
lidocaine topical system 5.4%
ZTlido
Three topical systems applied to the skin on the back for 12 hours.
ZTlido
lidocaine topical system 1.8%
Interventions
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SP-103
lidocaine topical system 5.4%
ZTlido
lidocaine topical system 1.8%
Eligibility Criteria
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Inclusion Criteria
* Body mass index ranging between 18.0-32.5 kg/m2, inclusive
* If childbearing potential, use of acceptable form of birth control
* In the case of females of childbearing potential, have a negative serum pregnancy test
Exclusion Criteria
* Any major medical illness 3 months prior or any significant history or ongoing chronic medical illness affecting the major body systems, including the skin
* Subjects with conditions that might affect application of the product or its adhesive properties (including psoriasis, eczema, atopic dermatitis, damaged or irritated epidermal layer, and excessive hair or oil on the skin)
* Use of antiarrhymthic drugs (such as tocainide and mexiletine) and local anesthetics within 14 days prior to product application.
* History of addiction, abuse, or misuse of any drug
* Use of nicotine-containing products within 30 days
18 Years
60 Years
ALL
Yes
Sponsors
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Scilex Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Peter Boldingh, PharmD
Role: PRINCIPAL_INVESTIGATOR
AXIS Clinicals
Locations
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AXIS Clinicals
Dilworth, Minnesota, United States
Countries
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Other Identifiers
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SCI-LIDO-PK-005
Identifier Type: -
Identifier Source: org_study_id
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