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Status unknownNCT05517486Updated Jan 23, 2023

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

A Phase 1 interventional study of GTX-101 and Bupivacaine HCl subcutaneous injection in Postherpetic Neuralgia, sponsored by Grace Therapeutics Inc.. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-23.

Sponsored by Grace Therapeutics Inc. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Postherpetic Neuralgia
03

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    50 mg GTX-101

    Drug: GTX-101

  • Experimental
    100 mg GTX-101

    Drug: GTX-101

  • Experimental
    200 mg GTX-101

    Drug: GTX-101

  • Active comparator
    Bupivacaine subcutaneous injection

    Drug: Bupivacaine HCl subcutaneous injection

Interventions

  • DrugGTX-101

    Bupivacaine HCl metered spray

    Also known as: Bupivacaine HCl metered spray

  • DrugBupivacaine HCl subcutaneous injection

    Bupivacaine HCl, 50 mg/10 mL

05

What researchers measure

Primary outcomes

  1. Cmax between 0 hour to 240 hour after study drug administration

    Maximum concentration occuring at Tmax

    Time frame: From 0 hour to 240 hour after study drug administration

  2. Tmax between 0 hour to 240 hour after study drug administration

    Time of maximum observed concentration

    Time frame: From 0 hour to 240 hour after study drug administration

  3. AUC last

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

    Time frame: From 0 hour to 240 hour after study drug administration

  4. AUC inf

    Area under the concentration time curve extrapolated to infinity

    Time frame: From 0 hour to 240 hour after study drug administration

06

Study locations

1 site
  • Clinical Research Unit
    Montréal, Canada
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05517486
Lead sponsor
Grace Therapeutics Inc.
Responsible party
Sponsor
First posted
Aug 26, 2022
Start date
Jul 26, 2022
Primary completion
Aug 21, 2022
Completion
May 3, 2023 (estimated)
Last update
Jan 23, 2023

Study contacts

Eric Sicard, MD
principal investigator · Clinical Research Unit

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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