A Pilot Study to Investigate the Safety, Efficacy, Pharmacokinetics and Bioavailability of HTX-011 Administered Via Injection or Topical Application Following Unilateral Open Inguinal Herniorrhaphy



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:5/19/2016
Start Date:July 2015
Contact:Guy Boccia, MA
Email:GBoccia@herontx.com
Phone:1-858-703-6064

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A Phase 2, Randomized, Double Blind, Pilot Study to Investigate the Safety, Efficacy,
Pharmacokinetics and Bioavailability of HTX-011 Administered Via Injection or Topical
Application Following Unilateral Open Inguinal Herniorrhaphy.


Inclusion Criteria:

1. Be male or female 18 years of age or older.

2. Female subjects are eligible only if all of the following apply:

Not pregnant (female subject of child bearing potential must have a negative serum
pregnancy test at screening and negative urine pregnancy test before surgery)

- Not lactating

- Not planning to become pregnant during the study

- Be surgically sterile; or at least two years post-menopausal; or have a
monogamous partner who is surgically sterile; or is practicing double-barrier
contraception; or practicing abstinence (must agree to use double-barrier
contraception in the event of sexual activity); or using an insertable,
injectable, transdermal, or combination oral contraceptive approved by the FDA
for greater than 2 months prior to screening visits and commits to the use of an
acceptable form of birth control for the duration of the study and for 30 days
from completion of the study

Male:

o Must be surgically sterile (biologically or surgically) or commit to the use of a
reliable method of birth control for the duration of the study until at least 1 week
after the administration of study medication.

3. Plan to undergo a unilateral inguinal herniorrhaphy

4. Have the ability and be willing to comply with the study procedures

5. Must be able to understand study procedures and give informed consent for the conduct
for all study procedures, using an IRB approved consent form.

Exclusion Criteria:

1. Unwilling to sign informed consent or not willing or able to complete all study
procedures

2. Have a contraindication or be allergic to any medication to be used during the trial
period

3. Have clinically significant cardiac abnormalities, that in the opinion of the
investigator would pose a health risk to the subject should they participate in the
trial

4. Have American Society of Anesthesiologists (ASA) Physical Status classification
system category 4 or greater (Appendix E)

5. Have clinically significant renal or hepatic abnormalities (defined as an AST or ALT
> 3x ULN, creatinine > 2x ULN)

6. Have another painful condition that may confound pain assessments

7. Have another surgery planned within 30 days of procedure, or presents with bilateral
or recurrent inguinal hernia, other hernia presentations, or hernias with large
scrotal component that would be difficult to reduce surgically

8. Have a known or suspected history of alcohol or drug abuse, or a positive drug screen

9. Currently taking analgesics for a chronically painful condition, or has taken long
acting opioids within 3 days of surgery, or taken any opioids within 24 hours of
surgery

10. Subjects with documented sleep apnea or are on home continuous positive airway
pressure (CPAP)

11. Female subjects who are pregnant (positive pregnancy test at screening or on the day
of surgery)

12. Subjects who are receiving oxygen therapy at the time of screening

13. Have participated in a clinical trial within 30 days of planned surgery

14. Have a body mass index (BMI) > 39 kg/m2
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