A Phase 2/3, Randomized, Double-blind, Comparator- and Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Efficacy of TLC590 for Postsurgical Pain Management Following Inguinal Hernia Repair

TLC590A2003

A phase 2/3 randomized, double-blind, 2-part, comparator- and placebo-controlled study to assess the safety, pharmacokinetics and efficacy of postsurgical local infiltration in adult subjects following inguinal hernia repair surgery.

2025-04-01

2025-12-01

2025-12-01

Not yet recruiting

Early phase I

415

Inclusion Criteria: * Male or female at least 18 years old * BMI 18-39 kg/m2 * Scheduled to undergo a primary, unilateral Lichtenstein inguinal hernia repair with mesh * ASA Physical Status Classification of 1, 2 or 3 Exclusion Criteria: * Clinically significant abnormal clinical laboratory test value * Clinically significant 12-lead ECG * History of orthostatic hypotension or syncope * History of significant renal, hepatic, gastrointestinal, cardiovascular, metabolic, neurologic, psychiatric, or other condition * History of seizure or currently taking anticonvulsants * History of hypersensitivity to bupivacaine/ropivacaine, any other amide-type local anesthetic, propofol, oxycodone or morphine (or other opioids) * History of severe or refractory post-operative nausea or vomiting (PONV) * Abnormalities of laboratory parameters: HbA1c, platelet, hemoglobin, WBC, serun bilirubin/alanine aminotransferase/aspartate aminotrasferase, serum creatinine, PTT/INR * Concurrent acute, or chronic painful restrictive/physical condition * Received opioid therapy for longer than 4 days per week * Prohibited medication: aspirin and other anti-platelet medication, anticoagulants, class III antiarrhythmic drugs, strong CYP1A2 inhibitors,systemic corticosteroids, NSAID, opioid, bupivacaine or ropivacaine, any investigational product * History of drug abuse or alcohol abuse * Positive results on the urine drug screen or alcohol breath test * History of HIV; active HBV or HCV * An inguinal hernia repair in the last 3 months or has undergone 3 or more surgeries within 12 months * Malignancy in the last 2 years * Documented sleep apnea or on home continuous positive airway pressure treatment (CPAP) * Personal or family history of malignant hyperthermia.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 415, 'type': 'ESTIMATED'}}

2024-04-11