Clinical trial NCT03591146 (phase 1/phase 2, status: completed)
Conditions: inguinal hernia
ICD codes: K40.11, K40.41, K40.01, K40.21, K40.31, K40.91, K40.10
Drugs: tlc590, naropin
SMILES: CCCN1CCCC[C@H]1C(=O)NC1=C(C)C=CC=C1C
Eligibility criteria:

        Inclusion Criteria:

          1. Able and willing to provide a written informed consent.

          2. Male or female between 18 and 65 years of age.

          3. Scheduled to undergo a primary, unilateral Lichtenstein inguinal hernia repair with
             mesh, and be able to use the anesthesia regimen.

          4. ASA Physical Status Classification of 1 or 2.

          5. Female subjects are eligible only if: not pregnant; not lactating; not planning to
             become pregnant during the study; commits to the use of an acceptable form of birth
             control.

          6. Male subjects must be sterile 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 blinded study medication.

          7. Body mass index ≤ 35 kg/m2.

        Exclusion Criteria:

          1. Clinically significant abnormal clinical laboratory test value.

          2. Evidence of a clinically significant 12-lead ECG.

          3. History or evidence of orthostatic hypotension, syncope or other syncopal attacks.

          4. History or clinical manifestations of significant renal, hepatic, gastrointestinal,
             cardiovascular, metabolic, neurologic, psychiatric, or other condition.

          5. History of seizures or are currently taking anticonvulsants.

          6. History of hypersensitivity to ropivacaine, any other amide-type local anesthetic,
             propofol, hydromorphone or oxycodone (or other opioids).

          7. Persistent or recurrent nausea and/or vomiting due to other etiologies, including, but
             not limited to gastric outlet obstruction, hypercalcemia, or active peptic ulcer.

          8. History of severe or refractory post-operative nausea or vomiting deemed clinically
             significant.

          9. Concurrent painful condition that may require analgesic treatment during the study
             period.

         10. Have been receiving or have received chronic opioid therapy.

         11. Use of any of the following medications within 5 half-lives or as specified prior to
             the study surgical procedure:

             Anti-platelet agents such as aspirin therapy within 7 days; clopidogrel within 5 days;
             Anticoagulants such as warfarin within 5 days; dabigatran etexilate mesylate within 2
             days; factor Xa inhibitor within 24 hours; Class III antiarrhythmic drugs (e.g.,
             amiodarone); Strong CYP1A2 inhibitors, such as cimetidine, ciprofloxacin, enoxacin,
             and fluvoxamine; CYP1A2 substrates, such as theophylline or imipramine; Strong CYP3A4
             inhibitors such as voriconazole, erythromycin, ketoconazole, or ritonavir; CYP3A4
             substrates, such as atazanavir, darunavir, indinavir, lopinavir, nelfinavir,
             ritonavir, saquinavir, or tipranavir; Corticosteroids, either systemically, inhaled,
             intranasally, orally, or by intra-articular injection within 14 days before the study
             surgical procedure (topical corticosteroid is allowed); Non-steroidal
             anti-inflammatory drugs (NSAIDs) within 14 days prior to the study surgical procedure;
             Any investigational product within 30 days prior to administration of blinded study
             medication.

         12. History of alcohol abuse or prescription and/or illicit drug abuse within 2 years.

         13. Current report of alcohol abuse within 6 months.

         14. Positive results on the urine drug screen or alcohol breath test indicative of illicit
             drug or alcohol abuse.

         15. History of human immunodeficiency virus (HIV), hepatitis C, or hepatitis B.

         16. Have had an inguinal hernia repair in the last 3 months before the study surgical
             procedure or presents with bilateral or recurrent inguinal hernia, other hernia
             presentations, or hernias with a large scrotal component that would be difficult to
             reduce surgically.