Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05114265
Other study ID # KUR-101-101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date February 15, 2022
Est. completion date October 12, 2022

Study information

Verified date December 2022
Source Kures, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date October 12, 2022
Est. primary completion date October 12, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - Healthy male and female subjects; - Between 18 and 55 years of age; - Provide a signed EC-approved consent form; - Generally healthy, in the opinion of the Investigator; - Body Mass Index (BMI) 18 to 32 kg/m^2; - Using method of contraception; - Willing and able to comply with protocol requirements for the duration of the study Exclusion Criteria: - Subjects taking prohibited medications; - Subjects with a history or presence of clinically significant medical or psychiatric disease; - Subjects with a history of recreational or opiate use; - Subjects with a history of alcohol abuse or moderate to severe substance abuse; - Subjects who have regularly used nicotine-containing products; - Subjects with a hospital admission or major illness within 1 month prior to Screening; - Subjects with a major surgery within 3 months prior to Screening; - Subjects who are pregnant or breastfeeding - Subjects who have participated (taken investigative drug and/or device) in another clinical trial within 30 days prior to Screening; - Subjects who belong to a vulnerable population.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
KUR-101
Single oral dose of KUR-101
OxyNorm
Single oral dose of OxyNorm
Placebo
Single oral dose of placebo

Locations

Country Name City State
New Zealand KUR-101-101 Clinical Research Site Christchurch

Sponsors (1)

Lead Sponsor Collaborator
Kures, Inc.

Country where clinical trial is conducted

New Zealand, 

Outcome

Type Measure Description Time frame Safety issue
Other Part 1: Effect of KUR-101 on evoked pain response as compared to placebo Measured using the cold pressor test Day 1 up to 4 hours post dose
Other Part 1: Addictive potential of KUR-101 when compared with placebo Measured through the Desire for Opioids visual acuity scale Up to 4 hours post dose
Other Part 1: Addictive potential of KUR-101 when compared with placebo Measured through the Addiction Research Center Inventory Morphine Benzedrine Group scale Up to 4 hours post dose
Primary Part 1: Safety of KUR-101 when compared with placebo Measured by the incidence of treatment-emergent adverse events From the signing of the informed consent through Day 8 in Cohort 1, 2, 4 and 5 and through Day 15 in Cohort 3
Primary Part 2: Effect of KUR-101 on evoked pain response as compared to oxycodone and placebo Measured using the cold pressor test Up to 4 hours post dose
Primary Part 2: Effect of KUR-101 on evoked pain response as compared to oxycodone and placebo Measured using thermal sensory testing Up to 4 hours post dose
Secondary Part 1 and Part 2: Pharmacokinetics of KUR-101 Measured by levels of KUR-101 in the blood Up to 48 hours post dose
Secondary Part 1: Pharmacokinetics of KUR-101 Measured by levels of KUR-101 in the urine Up to 48 hours post dose
Secondary Part 1: Effect of KUR-101 on respiratory function when compared to placebo Measured using continuous end-tidal capnography monitoring Up to 8 hours post dose
Secondary Part 1: Effect of KUR-101 on respiratory function when compared to placebo Measured using pulse oximetry Up to 8 hours post dose
Secondary Part 1: Effect of KUR-101 on respiratory function when compared to placebo Measured using vital signs monitoring Up to 8 hours post dose
Secondary Part 2: Effect of KUR-101 on respiratory function when compared to placebo and oxycodone Measured using continuous end-tidal capnography monitoring Up to 8 hours post dose
Secondary Part 2: Effect of KUR-101 on respiratory function when compared to placebo and oxycodone Measured using pulse oximetry Up to 8 hours post dose
Secondary Part 2: Effect of KUR-101 on respiratory function when compared to placebo and oxycodone Measured using vital signs monitoring Up to 8 hours post dose
Secondary Part 2: Safety of KUR-101 when compared with placebo and oxycodone Measured by the incidence of treatment-emergent adverse events From the signing of the informed consent through Day 22
Secondary Part 2: Addictive potential of KUR-101 when compared with placebo and oxycodone Measured through the Desire for Opioids visual acuity scale Up to 4 hours post dose
Secondary Part 2: Addictive potential of KUR-101 when compared with placebo and oxycodone Measured through the Addiction Research Center Inventory Morphine Benzedrine Group scale Up to 4 hours post dose
See also
  Status Clinical Trial Phase
Completed NCT04484610 - Appropriate Opioid Quantities for Acute Pain - Pharmacist Study Phase 4
Recruiting NCT05054179 - Pecto-Intercostal Fascial Plane Block Catheter Trial for Reduction of Sternal Pain Phase 2/Phase 3
Completed NCT04548635 - VR for Burn Dressing Changes at Home Phase 2/Phase 3
Recruiting NCT05370404 - Prescribing vs. Recommending Over-The-Counter (PROTECT) Analgesics for Patients With Postoperative Pain: N/A
Completed NCT06054945 - Clinical Impact of IPACK Block Addition to Suprainguinal Fascia Iliaca Block
Completed NCT03825549 - A Randomized Trial of Behavioral Economic Approaches to Reduce Unnecessary Opioid Prescribing N/A
Completed NCT05995912 - Efficacy and Safety of Etoricoxib-tramadol Tablet in Acute Postoperative Pain Phase 2
Recruiting NCT05589246 - Regional Analgesia in Combination With Cryoanalgesia to Prevent Acute Pain Following Nuss Procedure N/A
Recruiting NCT05572190 - Evaluate the Safety and Pharmacokinetic Profile of ETR028 and ETR029 in Healthy Adult Subjects Phase 1
Terminated NCT04716413 - Evaluating the Use of Sublingual Sufentanil in Patients With Suboxone Treatment Phase 4
Active, not recruiting NCT03537573 - Provider-Targeted Behavioral Interventions to Prevent Unsafe Opioid Prescribing for Acute Pain in Primary Care N/A
Not yet recruiting NCT06317844 - Examination of Psychological and Physiological Pathways Linking Gratitude and Pain N/A
Withdrawn 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 NCT02380989 - Integrative Ayurveda Healing Relieves Minor Sports Injury Pain Phase 2
Completed NCT02984098 - 40% Orally Administered Dextrose Gel is More Effective Than 25% Dextrose Phase 4
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