A Study to Evaluate LB1148 for Return of Bowel Function in Subjects Undergoing Bowel Resection

A Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety and Efficacy of LB1148 in Accelerating the Time to Return of Bowel Function in Subjects Undergoing Planned Bowel Resection (INTEGRITY)

The purpose of this study is to evaluate the safety and efficacy of LB1148 in subjects undergoing planned bowel resection.

This will be a multicenter, randomized, double-blind, placebo-controlled, study to evaluate the safety and efficacy of LB1148 in return to bowel function for subjects undergoing planned bowel resection.

Inclusion Criteria:

Subjects will be eligible for participation in the study only if they meet ALL of the following inclusion criteria:

1. Adults age 18 to 80 years, inclusive.
2. Scheduled to undergo a planned (non-emergent) bowel resection via minimally invasive technique or laparotomy. This includes any subject in which a resection of the small intestine, colon, or rectum is performed for any elective indication.
3. Willing to perform and comply with all study procedures including, being hospitalized until achieving GI-2 and responding to telephone follow-up visits as scheduled.
4. Willing and able to provide written informed consent.

Exclusion Criteria:

Subjects will not be eligible for participation in the study if they meet ANY of the following exclusion criteria:

1. History of total colectomy.

2. Has a preexisting ostomy.

3. History of radiation enteritis.

4. Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2.

5. History of seizure disorder.

6. History of myeloproliferative disorders.

7. American Society of Anesthesiologists (ASA) Class IV or V.

8. Inability to take IP orally or consume solid food.

9. Planned treatment with alvimopan (Entereg®) during hospitalization period

10. Chronic opioid usage, defined by the American Pain Society as daily or near-daily use of opioids for at least 90 days.

11. Men and women of child bearing potential (WOCBP) who are unwilling to practice a highly effective method of contraception that may include, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with vasectomized partner, vasectomy, hysterectomy, bilateral tubal ligation, licensed hormonal methods (but not combination hormonal methods), intrauterine device, or use of spermicide combined with a barrier method (e.g., condom, diaphragm) for 28 days before Day 1 and through Day 30.

12. Women who will not agree to stop combined hormonal contraceptive and or combined hormonal replacement therapy (including combined hormonal pill, patch or vaginal ring) during the 7 day period prior to Surgery (Study Day 2) through the 7 day period following surgery (Study Days 3 through 9).

13. Has contraindications or potential risk factors to taking TXA. These include subjects with:

    • Known sensitivity to TXA
    • Recent craniotomy (past 30 days)
    • Active cerebrovascular bleed
    • Active thromboembolic disease (such as deep vein thrombosis, pulmonary embolism, cerebral thrombosis, ischemic stroke, or acute coronary syndrome)
    • Acute promyelocytic leukemia taking all-trans retinoic acid for remission induction

14. Receipt of any investigational drug within 28 days or 5 half-lives prior to Day 1.

15. Any other condition that, in the opinion of the Investigator would make the subject unsuitable for the study or unable to comply with the study requirements.