Single-dose to Evaluate the Pharmacokinetics of GTX-101 and Subcutaneous Injectable Bupivacaine in Healthy Subjects
NCT ID: NCT05517486
Last Updated: 2023-01-23
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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UNKNOWN
PHASE1
48 participants
INTERVENTIONAL
2022-07-26
2023-05-03
Brief Summary
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The study will enroll subjects to evaluate the PK of 3 dose strengths (50 mg, 100 mg and 200 mg) of GTX-101 compared to Subcutaneous injection in healthy adult subjects.
Blood samples for PK assessments will be collect at specified time points. Safety assessments will also be performed throughout the study.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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50 mg GTX-101
GTX-101
Bupivacaine HCl metered spray
100 mg GTX-101
GTX-101
Bupivacaine HCl metered spray
200 mg GTX-101
GTX-101
Bupivacaine HCl metered spray
Bupivacaine subcutaneous injection
Bupivacaine HCl subcutaneous injection
Bupivacaine HCl, 50 mg/10 mL
Interventions
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GTX-101
Bupivacaine HCl metered spray
Bupivacaine HCl subcutaneous injection
Bupivacaine HCl, 50 mg/10 mL
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Healthy adult male or female, aged 18 to 55 years, inclusive, at Screening
* Body mass index (BMI) within 18.0 kg/m2 to 30.0 kg/m2, inclusively at Screening
* Have no clinically significant diseases captured in the medical/surgical history or evidence of clinically significant findings on the physical examination (including vital signs), weight and/or clinical laboratory tests and/or ECG, as determined by an Investigator
Exclusion Criteria
* Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
* History of significant gastrointestinal, liver or kidney disease that may affect drug bioavailability
18 Years
55 Years
ALL
Yes
Sponsors
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Grace Therapeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Eric Sicard, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Research Unit
Locations
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Clinical Research Unit
Montreal, , Canada
Countries
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Other Identifiers
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GTX-101-004
Identifier Type: -
Identifier Source: org_study_id
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