None listed
Conditions
Interventions
Drug : [VVZ-149 Treatment Group]
VVZ-149 Injection (180 mg) will be mixed with normal saline and administered as an intravenous infusion over 30 minutes on Day 1 and Day 7.
[Placebo Group]
Placebo wi
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged 19 to 70 years. 2. Female subjects who are not pregnant or breastfeeding. 3. Subjects with moderate or greater intensity of low back pain. 4. Subjects whose pain intensity (VAS) is 4.0 or higher, as measured at screening and before administration of the investigational drug. 5. Subjects who voluntarily sign the informed consent form and are able to understand the purpose and procedures of the study.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women. 2. Subjects whose pain intensity (VAS) exceeds 9.0, as measured at screening and before administration of the investigational drug. 3. Subjects with serious pathological conditions that cause pain such as spinal inflammatory diseases, spinal fractures, neurological disorders (neuropathic pain), spinal infections, or spinal tumors. 4. Subjects with radiating pain in body areas other than the lower extremities. 5. Subjects whose radiating pain is more severe than their lower back pain. 6. Subjects with a surgical history in the pain area or who have received nerve block procedures (e.g., epidural steroid injection, joint block) within the past 3 months. 7. Subjects who weigh less than 45 kg. 8. Subjects with unstable medical conditions (e.g., unstable angina, congestive heart failure, renal failure, hepatic failure, AIDS) or poorly controlled psychiatric disorders (e.g., untreated PTSD, anxiety, depression). 9. Subjects with QRS(QRS complex interval) > 200 msec or QTc(Corrected QT interval) > 450 msec (males) / QTc(Corrected QT interval) > 470 msec (females) on ECG at screening. 10. Subjects with a history of alcohol, opioid, or other substance abuse or dependence within 12 months prior to screening (per DSM-5 criteria). 11. Subjects who consumed alcohol within 24 hours prior to administration of the investigational drug. 12. Subjects who used drugs known to increase PR(PR interval) or QRS(QRS complex interval) intervals (Appendix A) within 24 hours prior to administration of the investigational drug. 13. Subjects who used CYP3A inhibitors/inducers or drugs metabolized by renal transporters OCT2 and MATE1/2K (Appendix B) within 24 hours prior to administration. 14. Subjects who received other investigational drugs within 30 days prior to screening. [Appendix A] Medications Known to Increase PR or QRS Interval - PR Interval Prolongation: Digoxin (Digitek®, Lanoxin®), Donepezil (Aricept®), Naratriptan (Amerge®), Propranolol (Atenolol®, Metoprolol®), Sumatriptan (Imitrex®), Verapamil (®) - QRS Interval Prolongation: Amiodarone, Amitriptyline, Amodiaquine, Amoxapine, Bupivacaine, Bupropion, Carbamazepine, Chloroquine (Aralen®), Citalopram, Desethylamodiaquine, Desipramine, Diltiazem, Diphenhydramine, Dolasetron, Fluoxetine, Imipramine, Lamotrigine, Maprotiline, Mesoridazine, Nortriptyline, Perhexiline, Procaine, Quetiapine (Seroquel®), Quinine, Risperidone, Ropivacaine, Thioridazine, Venlafaxine [Appendix B] CYP3A inhibitors or inducers, drugs metabolised by OCT2 and MATE1/2 - CYP3A Inhibitors(Weak): chlorzoxazone, cilostazol, fosaprepitant, istradefylline, ivacaftor, lomitapide, ranitidine, ranolazine, tacrolimus, ticagrelor - CYP3A Inhibitors(Moderate): aprepitant, cimetidine, ciprofloxacin, clotrimazole, crizotinib, cyclosporine, dronedarone, erythromycin, fluconazole, fluvoxamine, imatinib, tofisopam, verapamil - CYP3A Inhibitors(Strong): boceprevir, cobicistat, conivaptan, danoprevir and ritonavir, elvitegravir and ritonavir, grapefruit juice, indinavir and ritonavir, itraconazole, ketoconazole, lopinavir and ritonavir, paritaprevir and ritonavir and (ombitasvir and/or dasabuvir), posaconazole, ritonavir, saquinavir and ritonavir, telaprevir, tipranavir and ritonavir, troleandomycin, voriconazole, clarithromycin, diltiazem, idelalisib, nefazodone, nelfinavir - CYP3A Inducers(Weak): armodafinil, rufinamide - CYP3A Inducers(Moderate): bosentan, efavirenz, etravirine, modafi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SPID D1 2h: Sum of Pain Intensity Difference (SPID) over 2 hours after Day 1 dosing.;PID D1_2h: Difference in pain intensity between 2 hours post-dose on Day 1 and pre-dose on Day 1.;%SPID D1_2h: Percentage of SPID 2h area relative to maximum possible area based on pre-dose pain intensity on Day 1.;Proportion of subjects with %SPID D1_2h = 10%, 20%, or 30%.;Patient Global Impression of Change (PGIC) for overall pain relief. | — |
Secondary
| Measure | Time frame |
|---|---|
| SPID D7_2h: Sum of pain intensity difference over 2 hours after Day 7 dosing.;PID D7_predose: Difference in pain intensity between pre-dose on Day 7 and pre-dose on Day 1.;PID D7_2h: Difference in pain intensity between 2 hours after Day 7 dosing and pre-dose on Day 1.;PID D3: Difference in pain intensity between Day 3 and pre-dose on Day 1. | — |
Countries
Korea, Republic of
Contacts
Public ContactChan Sik Kim
Asan Medical Center
Outcome results
None listed