Single-dose to Evaluate the Pharmacokinetics of GTX-101 and Subcutaneous Injectable Bupivacaine in Healthy Subjects

NCT05517486 | Unknown Phase 1 FDA Drug

• 1 other identifier: GTX-101-004
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postherpetic Neuralgia

Outcome Measures

Primary Outcomes (4)

• Cmax between 0 hour to 240 hour after study drug administration

  Maximum concentration occuring at Tmax

  From 0 hour to 240 hour after study drug administration

• Tmax between 0 hour to 240 hour after study drug administration

  Time of maximum observed concentration

  From 0 hour to 240 hour after study drug administration

• AUC last

  Area under the concentration time curve from the time of last dosing to the time of last quantifiable concentration (Tlast)

  From 0 hour to 240 hour after study drug administration

• AUC inf

  Area under the concentration time curve extrapolated to infinity

  From 0 hour to 240 hour after study drug administration

Study Arms (4)

50 mg GTX-101

EXPERIMENTAL

Drug: GTX-101

100 mg GTX-101

EXPERIMENTAL

Drug: GTX-101

200 mg GTX-101

EXPERIMENTAL

Drug: GTX-101

Bupivacaine subcutaneous injection

ACTIVE COMPARATOR

Drug: Bupivacaine HCl subcutaneous injection

Interventions

GTX-101 DRUG

Bupivacaine HCl metered spray

Also known as: Bupivacaine HCl metered spray

100 mg GTX-101; 200 mg GTX-101; 50 mg GTX-101

Bupivacaine HCl subcutaneous injection DRUG

Bupivacaine HCl, 50 mg/10 mL

Bupivacaine subcutaneous injection

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Grace Therapeutics Inc.: lead

Study Sites (1)

Clinical Research Unit

Montreal, Canada

Location

MeSH Terms

Conditions

Neuralgia, Postherpetic

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eric Sicard, MD

  Clinical Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: August 26, 2022
• Study Start: July 26, 2022
• Primary Completion: August 21, 2022
• Study Completion: May 3, 2023
• Last Updated: January 23, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)