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
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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.
196 studies on the registry are indexed under Neuralgia, Postherpetic; 28 are open to participants now.
This study's enrollment of 48 is below the median of 94 across 162 interventional studies indexed under Neuralgia, Postherpetic.
Browse Neuralgia, Postherpetic studies →Grace Therapeutics Inc. is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: GTX-101
Drug: GTX-101
Drug: GTX-101
Drug: Bupivacaine HCl subcutaneous injection
Bupivacaine HCl metered spray
Also known as: Bupivacaine HCl metered spray
Bupivacaine HCl, 50 mg/10 mL
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
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
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
AUC inf
Area under the concentration time curve extrapolated to infinity
Time frame: From 0 hour to 240 hour after study drug administration
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2022 to primary completion in Aug 2022, 0 months.
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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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Grace Therapeutics Inc.