Clinical Trials Logo

Clinical Trial Summary

This project is testing the safety, tolerability, pharmacokinetics (PK, the amount of study drug in your blood) and pharmacodynamics (PD, how the study drug affects your body) of single doses of a new drug called KUR-101. Up to 58 healthy men or women aged between 18-55 will be enrolled in this study in two parts. Part 1 will involve a single ascending (increasing) dose (SAD) where 40 participants (5 groups of 8) will be randomised (assigned randomly, like flipping a coin) to receive a single oral dose of the study drug or placebo. The placebo will look the same as the study drug but will not contain any medicine. Part 2: will involve a crossover design where 18 participants will be randomised to receive a single oral dose of each of three interventions (study drug, placebo or a marketed form of oxycodone). Each dose is separated by 7 days and the participants are randomised so they do not know the order of the interventions. For Part 1 the total participation will last 9 days, of which 4 days (3 nights) will be spent in the clinic. One group of subjects in Part 1 will return to the clinic to receive a second dose of drug given with a high fat breakfast. In this group, the total participation will last 16 days, of which 8 days (7 nights) will be spent in the clinic. For Part 2 the total participation will last 23 days, of which 9 days (8 nights) will be spent in the clinic.

Clinical Trial Description

This is a Phase 1, single-center, prospective, study of orally administered KUR-101 in normal healthy participants. The study will be conducted in two parts. Part 1 is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, PK, analgesic and respiratory effects of single ascending doses of orally administered KUR-101 in normal healthy participants. Once the MTD has been determined, this dose, or an alternate lower dose, will be taken into Part 2 of the study. Part 2 is a randomized, double-blind, placebo-controlled, three-period crossover study to assess the analgesic and respiratory effects of a single oral KUR-101 as compared to that of oxycodone in normal healthy participants. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05114265
Study type Interventional
Source Kures, Inc.
Contact Georgina Kilfoil
Phone +61 (0)432388772
Email [email protected]
Status Not yet recruiting
Phase Phase 1
Start date January 2022
Completion date June 2022

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT04484610 - Appropriate Opioid Quantities for Acute Pain - Pharmacist Study Phase 4
Completed NCT04548635 - VR for Burn Dressing Changes at Home Phase 2/Phase 3
Completed NCT03825549 - A Randomized Trial of Behavioral Economic Approaches to Reduce Unnecessary Opioid Prescribing N/A
Not yet recruiting NCT05054179 - Pecto-Intercostal Fascial Plane Block Catheter Trial for Reduction of Sternal Pain Phase 2/Phase 3
Active, not recruiting NCT03537573 - Provider-Targeted Behavioral Interventions to Prevent Unsafe Opioid Prescribing for Acute Pain in Primary Care N/A
Not yet recruiting NCT05014230 - Open Label Placebo to Reduce Prescription Opioid Use N/A
Not yet recruiting NCT03599479 - Virtual Reality Experiences on Acute Pain and Distress N/A
Not yet recruiting NCT02957097 - Gabapentin as a Pre-emptive Analgesic in Oral and Maxillofacial Surgical Procedures Phase 4
Completed NCT02565342 - Interscalene Brachial Plexus Block to Treat Pain After Clavicular Surgery Phase 4
Terminated NCT02599870 - Clinical Study to Evaluate Clinical Impact of PGx-Guided Treatment for Patients Undergoing Elective Spinal Surgical Procedures N/A
Completed NCT02984098 - 40% Orally Administered Dextrose Gel is More Effective Than 25% Dextrose Phase 4
Completed NCT02380989 - Integrative Ayurveda Healing Relieves Minor Sports Injury Pain Phase 2
Completed NCT02489630 - Low Dose Ketamine as an Adjunct to Opiates for Acute Pain in the Emergency Department Phase 4
Completed NCT03107338 - Preventive Treatment of Pain After Dental Implant Surgery Phase 4
Completed NCT02817477 - Intranasal Ketamine for Acute Traumatic Pain Phase 4
Completed NCT00609466 - A Trial to Evaluate CG5503 Efficacy and Safety in Acute Pain After Bunionectomy Phase 3
Completed NCT00374881 - A Study of the Safety and Efficacy of Combination Therapy With Morphine, Phenylephrine and Sorbitol in Human Subjects Phase 1/Phase 2
Completed NCT00226395 - Efficacy and Safety of Oxymorphone Immediate Release in Post-surgical Acute Pain Phase 3
Completed NCT03664622 - Ketamine Versus Morphine Change Pain Profile N/A
Completed NCT03560427 - Duloxetine Potentiates the Analgesic Efficacy of Intrathecal Morphine N/A