PK and Safety After C-Section

October 29, 2026 updated by: Heron Therapeutics

A Phase 2, Open-Label Study of the Pharmacokinetics and Safety of HTX-011 Administered Postpartum to Women Undergoing a Planned Caesarean Section

The main goal of the study was to measure the amount of the active ingredients and other components of HTX-011 in plasma and expressed breast milk over time following postpartum administration in women undergoing a planned C-section. The study also looked at the safety of HTX-011 in these women.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Sheffield, Alabama, United States, 35660
        • Helen Keller Hospital
    • California
      • San Diego, California, United States, 92123
        • Sharp Mary Birch Hospital for Women and Newborns
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Magee-Womens Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Is expected, at the time of Screening visit, to deliver a single neonate.
  • Is scheduled to undergo a planned C-section surgery with a low transverse skin incision (eg, Pfannenstiel).
  • Has American Society of Anesthesiologists (ASA) Physical Status of I, II, or III.
  • Agrees to practice abstinence or use double-barrier contraception in the event of sexual activity and commits to the use of an acceptable form of birth control for 30 days after HTX-011 administration.
  • Agrees to refrain from the use of breast milk from this pregnancy in any manner.

Exclusion Criteria:

  • Has planned to breastfeed her neonate at any time during the 28-day period after HTX-011 administration.
  • Has had a prior full-term pregnancy with unsuccessful breast milk expression.
  • 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 been administered bupivacaine within 5 days prior to the scheduled surgery.
  • Has been administered any local anesthetic within 72 hours prior to the scheduled surgery.
  • Has been administered systemic steroids within 5 half-lives or 10 days prior to administration of study drug.
  • Has initiated treatment with study medications within 1 month prior to study drug administration that can impact pain control.
  • Has taken any NSAIDs within least 10 days prior to the scheduled surgery.
  • Has current significant placental abnormality/complications including, but not limited to, placenta previa or placenta accreta.
  • Has a medical condition such that, in the opinion of the Investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments.
  • 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 a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse.
  • Previously participated in an HTX-011 study.
  • Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half-lives.
  • Weight is <50 kg at the time of Screening visit.
  • In the Investigator's judgment, subject is likely to have been morbidly obese prior to her pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: HTX-011 300 mg/9 mg

HTX-011 (bupivacaine/meloxicam) 300 mg/9 mg via instillation
Drug: HTX-011

bupivacaine/meloxicam extended-release solution for instillation use, supplied in commercially available ZYNRELEF kits

Other Names:
  • ZYNRELEF
Device: ZYNRELEF kit components for administration

ZYNRELEF kits include sterile, individually packaged components for administration, including vented vial spikes, Luer lock syringes, custom Luer lock applicators, and syringe tip caps.
Experimental: HTX-011 400 mg/12 mg + MMA

HTX-011 (bupivacaine/meloxicam) 400 mg/12 mg via instillation + oral (PO) non-opioid multimodal analgesic (MMA) regimen
Drug: HTX-011

bupivacaine/meloxicam extended-release solution for instillation use, supplied in commercially available ZYNRELEF kits

Other Names:
  • ZYNRELEF
Device: ZYNRELEF kit components for administration

ZYNRELEF kits include sterile, individually packaged components for administration, including vented vial spikes, Luer lock syringes, custom Luer lock applicators, and syringe tip caps.

Drug: MMA regimen

PO ibuprofen 400 mg every 6 hours (q6h), alternating with PO acetaminophen 975 mg to 1 g q6h, alternating the 2 medications so that an analgesic was taken approximately every 3 hours (q3h) while the subject was awake

Other Names:
  • ibuprofen, acetaminophen

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Bupivacaine Plasma Cmax
Time Frame: Day 1 to Day 16 for Cohort 1 (HTX-011 300 mg/9 mg); Day 1 to Day 11 for Cohort 2 (HTX-011 400 mg/12 mg + MMA)

Maximum plasma concentration of bupivacaine
Day 1 to Day 16 for Cohort 1 (HTX-011 300 mg/9 mg); Day 1 to Day 11 for Cohort 2 (HTX-011 400 mg/12 mg + MMA)
Bupivacaine Plasma Tmax
Time Frame: Day 1 to Day 16 for Cohort 1 (HTX-011 300 mg/9 mg); Day 1 to Day 11 for Cohort 2 (HTX-011 400 mg/12 mg + MMA)

Time to maximum concentration of bupivacaine in plasma
Day 1 to Day 16 for Cohort 1 (HTX-011 300 mg/9 mg); Day 1 to Day 11 for Cohort 2 (HTX-011 400 mg/12 mg + MMA)
Bupivacaine Plasma t1/2
Time Frame: Day 1 to Day 16 for Cohort 1 (HTX-011 300 mg/9 mg); Day 1 to Day 11 for Cohort 2 (HTX-011 400 mg/12 mg + MMA)

Half life of bupivacaine in plasma
Day 1 to Day 16 for Cohort 1 (HTX-011 300 mg/9 mg); Day 1 to Day 11 for Cohort 2 (HTX-011 400 mg/12 mg + MMA)
Bupivacaine Plasma AUCinf
Time Frame: Day 1 to Day 16 for Cohort 1 (HTX-011 300 mg/9 mg); Day 1 to Day 11 for Cohort 2 (HTX-011 400 mg/12 mg + MMA)

Area under the bupivacaine plasma concentration-time curve from Time 0 extrapolated to infinity
Day 1 to Day 16 for Cohort 1 (HTX-011 300 mg/9 mg); Day 1 to Day 11 for Cohort 2 (HTX-011 400 mg/12 mg + MMA)
Bupivacaine Breast Milk Cmax
Time Frame: Day 1 to Day 16 for Cohort 1 (HTX-011 300 mg/9 mg); Day 1 to Day 11 for Cohort 2 (HTX-011 400 mg/12 mg + MMA)

Maximum concentration of bupivacaine in breast milk
Day 1 to Day 16 for Cohort 1 (HTX-011 300 mg/9 mg); Day 1 to Day 11 for Cohort 2 (HTX-011 400 mg/12 mg + MMA)
Bupivacaine Breast Milk Tmax
Time Frame: Day 1 to Day 16 for Cohort 1 (HTX-011 300 mg/9 mg); Day 1 to Day 11 for Cohort 2 (HTX-011 400 mg/12 mg + MMA)

Time to maximum concentration of bupivacaine in breast milk
Day 1 to Day 16 for Cohort 1 (HTX-011 300 mg/9 mg); Day 1 to Day 11 for Cohort 2 (HTX-011 400 mg/12 mg + MMA)
Bupivacaine Breast Milk AUClast
Time Frame: Day 1 to Day 16 for Cohort 1 (HTX-011 300 mg/9 mg); Day 1 to Day 11 for Cohort 2 (HTX-011 400 mg/12 mg + MMA)

Area under the bupivacaine breast milk concentration-time curve from Time 0 to time of last quantifiable concentration
Day 1 to Day 16 for Cohort 1 (HTX-011 300 mg/9 mg); Day 1 to Day 11 for Cohort 2 (HTX-011 400 mg/12 mg + MMA)
Meloxicam Plasma Cmax
Time Frame: Day 1 to Day 16 for Cohort 1 (HTX-011 300 mg/9 mg); Day 1 to Day 11 for Cohort 2 (HTX-011 400 mg/12 mg + MMA)

Maximum plasma concentrations of meloxicam
Day 1 to Day 16 for Cohort 1 (HTX-011 300 mg/9 mg); Day 1 to Day 11 for Cohort 2 (HTX-011 400 mg/12 mg + MMA)
Meloxicam Plasma Tmax
Time Frame: Day 1 to Day 16 for Cohort 1 (HTX-011 300 mg/9 mg); Day 1 to Day 11 for Cohort 2 (HTX-011 400 mg/12 mg + MMA)

Time to maximum meloxicam plasma concentration in plasma
Day 1 to Day 16 for Cohort 1 (HTX-011 300 mg/9 mg); Day 1 to Day 11 for Cohort 2 (HTX-011 400 mg/12 mg + MMA)
Meloxicam Plasma t1/2
Time Frame: Day 1 to Day 16 for Cohort 1 (HTX-011 300 mg/9 mg); Day 1 to Day 11 for Cohort 2 (HTX-011 400 mg/12 mg + MMA)

Half-life of meloxicam in plasma
Day 1 to Day 16 for Cohort 1 (HTX-011 300 mg/9 mg); Day 1 to Day 11 for Cohort 2 (HTX-011 400 mg/12 mg + MMA)
Meloxicam Plasma AUCinf
Time Frame: Day 1 to Day 16 for Cohort 1 (HTX-011 300 mg/9 mg); Day 1 to Day 11 for Cohort 2 (HTX-011 400 mg/12 mg + MMA)

Area under the meloxicam plasma concentration-time curve from Time 0 extrapolated to infinity
Day 1 to Day 16 for Cohort 1 (HTX-011 300 mg/9 mg); Day 1 to Day 11 for Cohort 2 (HTX-011 400 mg/12 mg + MMA)
Meloxicam Breast Milk Cmax
Time Frame: Day 1 to Day 16 for Cohort 1 (HTX-011 300 mg/9 mg); Day 1 to Day 11 for Cohort 2 (HTX-011 400 mg/12 mg + MMA)

Maximum concentration of meloxicam in breast milk
Day 1 to Day 16 for Cohort 1 (HTX-011 300 mg/9 mg); Day 1 to Day 11 for Cohort 2 (HTX-011 400 mg/12 mg + MMA)
Meloxicam Breast Milk Tmax
Time Frame: Day 1 to Day 16 for Cohort 1 (HTX-011 300 mg/9 mg); Day 1 to Day 11 for Cohort 2 (HTX-011 400 mg/12 mg + MMA)

Time to maximum meloxicam concentration in breast milk
Day 1 to Day 16 for Cohort 1 (HTX-011 300 mg/9 mg); Day 1 to Day 11 for Cohort 2 (HTX-011 400 mg/12 mg + MMA)
Meloxicam Breast Milk AUClast
Time Frame: Day 1 to Day 16 for Cohort 1 (HTX-011 300 mg/9 mg); Day 1 to Day 11 for Cohort 2 (HTX-011 400 mg/12 mg + MMA)

Area under the meloxicam breast milk concentration-time curve from Time 0 to time of last quantifiable concentration
Day 1 to Day 16 for Cohort 1 (HTX-011 300 mg/9 mg); Day 1 to Day 11 for Cohort 2 (HTX-011 400 mg/12 mg + MMA)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Heron Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 24, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 3, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 27, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HTX-011-220

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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