Overview

HTX-011 Administration Study in Planned Caesarean Section Procedure

Status:
Recruiting
Trial end date:
2021-03-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Heron Therapeutics
Treatments:
Acetaminophen
Ibuprofen
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.