Clinical trial NCT03955211: HTX-011 Administration Study in Planned Caesarean Section Procedure
Official title: A Phase 2 Open-Label Study of the Pharmacokinetics (PK) and Safety of HTX-011 Administered Postpartum to Women Undergoing a Planned Caesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Analgesia
Keywords: postoperative pain
caesarean section
C-section
Lead sponsor: Heron Therapeutics
Sponsor class: INDUSTRY
First posted: 2019-05-20
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase 2, open-label study to evaluate the PK and safety of HTX-011 in women undergoing a planned C-section.


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum plasma concentration (Cmax) of bupivacaine, meloxicam, dimethyl sulfoxide (DMSO) and HTX-011 polymer
timeFrame: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
measure: Time of maximum plasma concentration (Tmax) of bupivacaine, meloxicam, DMSO and HTX-011 polymer
timeFrame: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
measure: Half life (t1/2) in plasma of bupivacaine, meloxicam, DMSO and HTX-011 polymer
timeFrame: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
measure: Half life (t1/2) in milk of bupivacaine, meloxicam, DMSO and HTX-011 polymer
timeFrame: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
measure: Amount of analyte excreted in breast milk over time (Ae)
timeFrame: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
measure: Fraction of dose excreted in breast milk over time (Fe)
timeFrame: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Secondary outcomes:
measure: Mean area under the curve of the NRS pain scores through 72 hours (AUC0-72).
timeFrame: 72 hours
measure: Incidence of treatment-emergent adverse events (TEAEs).
timeFrame: 28 Days.
Other outcomes:
Locations:
city: Sheffield
country: United States
facility: Helen Keller Hospital
state: Alabama
city: San Diego
country: United States
facility: Sharp Mary Birch Hospital for Women and Newborns
state: California
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Pittsburgh
country: United States
facility: UPMC Magee-Womens Hospital
state: Pennsylvania
Study officials:
References: