Back to resultsDose-Escalation Study of HTX-034 Following Bunionectomy
Primary Purpose
Bunions
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
HTX-034
HTX-034
Luer lock applicator
Bupivacaine HCl
Sponsored by
About this trial
This is an interventional treatment trial for Bunions focused on measuring Analgesia, Bunionectomy
Eligibility Criteria
Inclusion Criteria:
- Is medically fit to undergo an elective unilateral, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia; no neuraxial technique (eg, no spinal, epidural, or general anesthesia).
- Has an American Society of Anesthesiologists (ASA) Physical Status of I, II, or III.
- Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study; sterile, or using acceptable contraceptives.
Exclusion Criteria:
- Had contralateral foot bunionectomy in the past 3 months.
- Has a planned concurrent surgical procedure.
- Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications.
- Has a pre-existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain.
- Has received or is taking a contraindicated or prohibited medications.
- Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half lives.
- Has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse.
- Has a history of clinically significant cardiac abnormality such as myocardial infarction within 6 months.
- Has a history of coronary artery bypass graft surgery within 12 months.
- Has a history of known or suspected coagulopathy.
- As per subject history and/or medical records, has active infection or is currently undergoing treatment for Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV).
- Has uncontrolled anxiety, psychiatric, or neurological disorder.
- Had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
- Has undergone 3 or more surgeries within 12 months.
- Has a known history of glucose-6-phosphate dehydrogenase deficiency.
Has any of the following laboratory abnormalities during Screening (1 retest permitted):
- Severe liver function impairment.
- Severe kidney function impairment.
- Platelet count <100,000/μL, hemoglobin <12 g/dL, or hematocrit <35%.
- Has a body mass index (BMI) >39 kg/m2.
Sites / Locations
- Arizona Research Center
- First Surgical Hospital
- Endeavor Clinical Trials, LLC
- JBR Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Phase 1b (Cohort 1)
Phase 1b (Cohort 2)
Phase 2 (Expansion): Low Dose
Phase 2 (Expansion): High Dose
Phase 1b and Phase 2
Arm Description
Fixed dose of HTX-034.
Individualized dose of HTX-034.
Fixed dose of HTX-034.
Individualized dose of HTX-034.
Bupivacaine HCl.
Outcomes
Primary Outcome Measures
Incidence of Treatment-emergent adverse events (TEAE's) (Phase 1B)
Mean area under the curve (AUC) of the NRS scores through 72 hours (AUC0-72) for the pooled Phase 1b and Phase 2
Secondary Outcome Measures
Maximum plasma concentration (Cmax) of HTX-034
Time of maximum plasma concentration (Tmax) of HTX-034
Area under the concentration-time curve from Time 0 to the time of the last quantitative concentration (AUClast) of HTX-034
Area under the concentration-time curve from Time 0 extrapolated to infinity (AUCinf) of HTX-034 (Phase 1B)
Apparent terminal half-life (t½) of HTX-034 (Phase 1B)
Mean AUC of the NRS pain intensity scores
Total postoperative opioid consumption (in IV Morphine Milligram Equivalents)
Proportion of subjects who are opioid-free
Incidence of serious adverse Events (SAE's)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04398329
Brief Title
Dose-Escalation Study of HTX-034 Following Bunionectomy
Official Title
A Phase 1b/2, Randomized, Blinded, Active-Controlled Study of Escalating Doses of HTX-034 for Postoperative Analgesia in Subjects Undergoing Unilateral, First Metatarsal Bunionectomy With Osteotomy and Internal Fixation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
May 18, 2020 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
August 3, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Heron Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
5. Study Description
Brief Summary
This is a Phase 1b/2, randomized, blinded, active-controlled study. Phase 1b will evaluate escalating doses of HTX-034 compared with bupivacaine HCl. Phase 2 will be a dose-expansion phase to evaluate additional subjects treated with the HTX-034 dose selected based on Phase 1b compared with bupivacaine HCl.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bunions
Keywords
Analgesia, Bunionectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phase 1b (Cohort 1)
Arm Type
Experimental
Arm Description
Fixed dose of HTX-034.
Arm Title
Phase 1b (Cohort 2)
Arm Type
Experimental
Arm Description
Individualized dose of HTX-034.
Arm Title
Phase 2 (Expansion): Low Dose
Arm Type
Experimental
Arm Description
Fixed dose of HTX-034.
Arm Title
Phase 2 (Expansion): High Dose
Arm Type
Experimental
Arm Description
Individualized dose of HTX-034.
Arm Title
Phase 1b and Phase 2
Arm Type
Active Comparator
Arm Description
Bupivacaine HCl.
Intervention Type
Drug
Intervention Name(s)
HTX-034
Intervention Description
HTX-034, low dose
Intervention Type
Drug
Intervention Name(s)
HTX-034
Intervention Description
HTX-034, high dose
Intervention Type
Device
Intervention Name(s)
Luer lock applicator
Intervention Description
Applicator for instillation
Intervention Type
Drug
Intervention Name(s)
Bupivacaine HCl
Intervention Description
Bupivacaine HCl, 50 mg
Primary Outcome Measure Information:
Title
Incidence of Treatment-emergent adverse events (TEAE's) (Phase 1B)
Time Frame
42 days
Title
Mean area under the curve (AUC) of the NRS scores through 72 hours (AUC0-72) for the pooled Phase 1b and Phase 2
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Maximum plasma concentration (Cmax) of HTX-034
Time Frame
29 days
Title
Time of maximum plasma concentration (Tmax) of HTX-034
Time Frame
29 days
Title
Area under the concentration-time curve from Time 0 to the time of the last quantitative concentration (AUClast) of HTX-034
Time Frame
29 days
Title
Area under the concentration-time curve from Time 0 extrapolated to infinity (AUCinf) of HTX-034 (Phase 1B)
Time Frame
22 days
Title
Apparent terminal half-life (t½) of HTX-034 (Phase 1B)
Time Frame
22 days
Title
Mean AUC of the NRS pain intensity scores
Time Frame
7 days
Title
Total postoperative opioid consumption (in IV Morphine Milligram Equivalents)
Time Frame
7 days
Title
Proportion of subjects who are opioid-free
Time Frame
14 days
Title
Incidence of serious adverse Events (SAE's)
Time Frame
42 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Is medically fit to undergo an elective unilateral, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia; no neuraxial technique (eg, no spinal, epidural, or general anesthesia).
Has an American Society of Anesthesiologists (ASA) Physical Status of I, II, or III.
Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study; sterile, or using acceptable contraceptives.
Exclusion Criteria:
Had contralateral foot bunionectomy in the past 3 months.
Has a planned concurrent surgical procedure.
Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications.
Has a pre-existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain.
Has received or is taking a contraindicated or prohibited medications.
Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half lives.
Has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse.
Has a history of clinically significant cardiac abnormality such as myocardial infarction within 6 months.
Has a history of coronary artery bypass graft surgery within 12 months.
Has a history of known or suspected coagulopathy.
As per subject history and/or medical records, has active infection or is currently undergoing treatment for Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV).
Has uncontrolled anxiety, psychiatric, or neurological disorder.
Had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
Has undergone 3 or more surgeries within 12 months.
Has a known history of glucose-6-phosphate dehydrogenase deficiency.
Has any of the following laboratory abnormalities during Screening (1 retest permitted):
Severe liver function impairment.
Severe kidney function impairment.
Platelet count <100,000/μL, hemoglobin <12 g/dL, or hematocrit <35%.
Has a body mass index (BMI) >39 kg/m2.
Facility Information:
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Facility Name
First Surgical Hospital
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Endeavor Clinical Trials, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
JBR Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84017
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Dose-Escalation Study of HTX-034 Following Bunionectomy
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