A Study on TLC590 for Managing Postsurgical Pain

Launched by TAIWAN LIPOSOME COMPANY · Aug 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called TLC590 to help manage pain after surgery. It aims to understand how the drug behaves in the body, how effective it is, and how safe it is for patients undergoing different types of elective surgeries, such as bunion surgery, hernia repair, breast augmentation, tummy tucks, and knee replacements. The researchers will also find out the highest dose of TLC590 that can be safely given to patients.

To participate in this study, you need to be between 18 and 70 years old and scheduled for one of the surgeries mentioned above. You should be in generally good health and able to provide consent to join the trial. Participants will receive TLC590 and will be monitored for any side effects and how well the medication works for pain management. It’s important to note that women who can become pregnant must use effective birth control during the study, and there are specific health conditions that could exclude someone from participating. This trial is currently recruiting patients, and those who join will contribute to important research that may improve pain management after surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Able and willing to provide written informed consent
• • 2. Male or female aged 18 to 70 years, inclusive. For the Part 2 breast augmentation surgical model, only females can be enrolled
• 3. Scheduled to undergo one of the following elective surgeries, with no additional procedures and be able to use the anesthesia regimen:
• • 1. Unilateral first metatarsal bunionectomy (Cohort 1)
• • 2. Laparoscopy-assisted open ventral hernia repair (Cohort 2 and 6)
• • 3. Breast augmentation (Cohort 3 through 5)
• • 4. Unilateral total knee arthroplasty (Cohort 7)
• • 5. Abdominoplasty (tummy tuck) (Cohort 8)
• • 4. ASA Physical Status Classification of 1 or 2
• • 5. Male subjects must be either biologically or surgically sterile or commit to the use of a reliable method of birth control (must agree to use double-barrier contraception in the event of sexual activity) or be practicing abstinence for the duration of the study and for 30 days after study drug administration
• 6. Female subjects are eligible only if all the following apply:
• • 1. Not pregnant with a negative serum pregnancy test at Screening and negative urine pregnancy test on Day 1 before surgery (pregnancy test not required for females of non-childbearing potential, defined as surgically sterile or post-menopausal)
• • 2. Not lactating
• • 3. Not planning to become pregnant during the study
• • 4. If of childbearing potential, commits to the use of a highly effective method of birth control for the duration of the study and or at least 30 days after study drug administration
• • 7. BMI \>18 \~ ≤39 kg/m2
• Exclusion Criteria:
• • 1. A clinically significant abnormal clinical laboratory test value
• • 2. Evidence of a clinically significant 12-lead ECG
• • 3. History of orthostatic hypotension, syncope, or other syncopal attacks
• • 4. History or any clinical manifestation of significant renal, hepatic, gastrointestinal, cardiovascular, metabolic, neurologic, psychiatric, or other condition that has been assessed by the Investigator to be unsuitable for participation in the study
• • 5. History of seizures or taking anticonvulsants during the Screening period
• • 6. History of cardiac arrhythmia or taking Class III antiarrhythmic drugs including amiodarone, dofetilide, dronedarone, sotalol, or ibutilide during the Screening period
• • 7. History of sleep apnea or on home CPAP treatment
• • 8. History of hypersensitivity to ropivacaine, any other amide-type local anesthetic, propofol, hydromorphone, fentanyl, midazolam, acetaminophen, oxycodone, or morphine (or other opioids)
• • 9. History of severe or refractory PONV due to other etiologies, including, but not limited to gastric outlet obstruction, hypercalcemia, or active peptic ulcer, deemed clinically significant by the Investigator
• • 10. Any lifetime history of a suicidal attempt or any suicidal behavior, as assessed by the C-SSRS at Screening
• • 11. History or positive test results of HIV, HCV, or HBV
• • 12. History or current report of substance abuse including illicit drug abuse and/or alcohol abuse (regularly drinks \>4 units of alcohol per day: 1 unit = 8 oz. beer, 3 oz. wine, or 1 oz. spirits) within 2 years prior to Screening
• • 13. Positive results on the urine drug screen or alcohol breath test indicative of illicit drug or non-prescribed drug or alcohol abuse at Screening or on Day 1 before surgery. Prescribed medication that is known to result in a positive drug test is allowed. Marijuana (medical or recreational) is not allowed
• • 14. Pre-existing concurrent acute, or chronic painful restrictive/physical condition that may confound postoperative pain assessments or is expected to require analgesic treatment during the study
• • 15. Has known or suspected daily use of opioids for longer than 4 days per week within the previous 6 months prior to Screening
• • 16. Is taking daily analgesics for longer than 4 days per week for a chronically painful condition during the Screening period. Not exclusionary if it is utilized for pain related to the total knee arthroplasty indication
• • 17. Is receiving oxygen therapy during the Screening period
• • 18. Use of any of the following medications within 5 half-lives prior to the study surgical procedure or as specified
• • 19. Malignancy in the last 2 years prior to Screening, except for non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix
• • 20. Personal or family history of malignant hyperthermia