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Clinical trial

Parallel Study to Evaluate the Pharmacokinetics, Dose Proportionality, Safety and Tolerability of GTX-101 (Bupivacaine Hydrochloride Metered Dose Spray) and Subcutaneous Injectable Bupivacaine in Healthy Subjects

ID
Name
GTX-101-004
Description
This is a single-center, randomized, single-dose, active-controlled study in healthy male and female subjects. 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.
Trial arms
Trial start
2022-07-26
Estimated PCD
2022-08-21
Trial end
2023-05-03
Status
Active (not recruiting)
Phase
Early phase I
Treatment
GTX-101
Bupivacaine HCl metered spray
Arms:
100 mg GTX-101, 200 mg GTX-101, 50 mg GTX-101
Other names:
Bupivacaine HCl metered spray
Bupivacaine HCl subcutaneous injection
Bupivacaine HCl, 50 mg/10 mL
Arms:
Bupivacaine subcutaneous injection
Size
48
Primary endpoint
Cmax between 0 hour to 240 hour after study drug administration
From 0 hour to 240 hour after study drug administration
Tmax between 0 hour to 240 hour after study drug administration
From 0 hour to 240 hour after study drug administration
AUC last
From 0 hour to 240 hour after study drug administration
AUC inf
From 0 hour to 240 hour after study drug administration
Eligibility criteria
Inclusion Criteria: * Provision of signed and dated informed consent form (ICF) * 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: * History of significant hypersensitivity to bupivacaine, local anesthetic agents of amide type, or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs * 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 48, 'type': 'ACTUAL'}}
Updated at
2023-01-23

1 organization

2 products

1 indication

Organization
Acasti Pharma
Product
GTX-101
Indication
Postherpetic Neuralgia
Product
Bupivacaine HCl