Postherpetic NeuralgiaPhase 1NCT05517486
Single-dose to Evaluate the Pharmacokinetics of GTX-101 and Subcutaneous Injectable Bupivacaine in Healthy Subjects
A Phase 1 study testing GTX-101 and Bupivacaine HCl subcutaneous injection in people with Postherpetic Neuralgia, run by Grace Therapeutics Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Postherpetic Neuralgia
- What is being tested?
- GTX-101 and Bupivacaine HCl subcutaneous injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- 26 Jul 2022to 3 May 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Being tested
- GTX-101, Bupivacaine HCl subcutaneous injection
- Medical subject headings
- Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GTX-101Drug
Also called Bupivacaine HCl metered spray
Bupivacaine HCl metered spray
Bupivacaine HCl subcutaneous injectionDrug
Bupivacaine HCl, 50 mg/10 mL
| Study group | Role | What they receive |
|---|---|---|
| 50 mg GTX-101 | Experimental | Not described Receives: Drug: GTX-101 |
| 100 mg GTX-101 | Experimental | Not described Receives: Drug: GTX-101 |
| 200 mg GTX-101 | Experimental | Not described Receives: Drug: GTX-101 |
| Bupivacaine subcutaneous injection | Active comparator | Not described Receives: Drug: Bupivacaine HCl subcutaneous injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax between 0 hour to 240 hour after study drug administration
Maximum concentration occuring at Tmax
Measured: 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
Measured: 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)
Measured: From 0 hour to 240 hour after study drug administration
AUC inf
Area under the concentration time curve extrapolated to infinity
Measured: From 0 hour to 240 hour after study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start26 Jul 2022
- Primary completion21 Aug 2022
- Study completion3 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postherpetic NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grace Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Sicard, MD, Principal investigator, Clinical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517486
- Sponsor's protocol ID
- GTX-101-004
- Status last verified
- Jun 2022
- First submitted
- 14 Jul 2022
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05517486
- Acronym / sponsor ID
- GTX-101-004
- Conditions
- Postherpetic Neuralgia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Grace Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Jul 2022 (actual)
- Primary completion
- 21 Aug 2022 (actual)
- Study completion
- 3 May 2023 (estimated)
- First posted
- 26 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GTX-101Also: Bupivacaine HCl metered sprayBupivacaine HCl metered spray | Drug | 100 mg GTX-101, 200 mg GTX-101, 50 mg GTX-101 |
| Bupivacaine HCl subcutaneous injectionBupivacaine HCl, 50 mg/10 mL | Drug | Bupivacaine subcutaneous injection |
Primary outcome
Cmax between 0 hour to 240 hour after study drug administration
Time frame: From 0 hour to 240 hour after study drug administration
Maximum concentration occuring at Tmax
Tmax between 0 hour to 240 hour after study drug administration
Time frame: From 0 hour to 240 hour after study drug administration
Time of maximum observed concentration
AUC last
Time frame: From 0 hour to 240 hour after study drug administration
Area under the concentration time curve from the time of last dosing to the time of last quantifiable concentration (Tlast)
AUC inf
Time frame: From 0 hour to 240 hour after study drug administration
Area under the concentration time curve extrapolated to infinity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Sicard, MD principal investigator
Clinical Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GTX-101 and Bupivacaine HCl subcutaneous injection in people with Postherpetic Neuralgia, run by Grace Therapeutics Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax between 0 hour to 240 hour after study drug administration (time frame: From 0 hour to 240 hour after study drug administration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023.