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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05114265
Registration number
NCT05114265
Ethics application status
Date submitted
19/10/2021
Date registered
9/11/2021
Titles & IDs
Public title
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of KUR-101 in Healthy Adults
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Scientific title
A Phase 1 Randomized, Double-Blind, Two Part Study of the Safety, Tolerability, Pharmacokinetics, Analgesic and Respiratory Effect of KUR-101 in Healthy Adult Participants
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Secondary ID [1]
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KUR-101-101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Pain
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Condition category
Condition code
Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - KUR-101
Treatment: Drugs - OxyNorm
Treatment: Drugs - Placebo
Experimental: Part 1: Single ascending dose - Single dose of oral KUR-101 or oral placebo
Experimental: Part 2: Three-way crossover - Single dose of oral KUR-101, oral placebo and oral OxyNorm
Treatment: Drugs: KUR-101
Single oral dose of KUR-101
Treatment: Drugs: OxyNorm
Single oral dose of OxyNorm
Treatment: Drugs: Placebo
Single oral dose of placebo
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Part 1: Safety of KUR-101 when compared with placebo
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Assessment method [1]
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Measured by the incidence of treatment-emergent adverse events
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Timepoint [1]
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From the signing of the informed consent through Day 8 in Cohort 1, 2, 4 and 5 and through Day 15 in Cohort 3
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Primary outcome [2]
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Part 2: Effect of KUR-101 on evoked pain response as compared to oxycodone and placebo
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Assessment method [2]
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Measured using the cold pressor test
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Timepoint [2]
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Up to 4 hours post dose
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Primary outcome [3]
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Part 2: Effect of KUR-101 on evoked pain response as compared to oxycodone and placebo
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Assessment method [3]
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Measured using thermal sensory testing
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Timepoint [3]
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Up to 4 hours post dose
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Secondary outcome [1]
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Part 1 and Part 2: Pharmacokinetics of KUR-101
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Assessment method [1]
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Measured by levels of KUR-101 in the blood
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Timepoint [1]
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Up to 48 hours post dose
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Secondary outcome [2]
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Part 1: Pharmacokinetics of KUR-101
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Assessment method [2]
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Measured by levels of KUR-101 in the urine
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Timepoint [2]
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Up to 48 hours post dose
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Secondary outcome [3]
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Part 1: Effect of KUR-101 on respiratory function when compared to placebo
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Assessment method [3]
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Measured using continuous end-tidal capnography monitoring
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Timepoint [3]
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Up to 8 hours post dose
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Secondary outcome [4]
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Part 1: Effect of KUR-101 on respiratory function when compared to placebo
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Assessment method [4]
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Measured using pulse oximetry
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Timepoint [4]
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Up to 8 hours post dose
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Secondary outcome [5]
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Part 1: Effect of KUR-101 on respiratory function when compared to placebo
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Assessment method [5]
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Measured using vital signs monitoring
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Timepoint [5]
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Up to 8 hours post dose
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Secondary outcome [6]
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Part 2: Effect of KUR-101 on respiratory function when compared to placebo and oxycodone
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Assessment method [6]
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Measured using continuous end-tidal capnography monitoring
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Timepoint [6]
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Up to 8 hours post dose
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Secondary outcome [7]
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Part 2: Effect of KUR-101 on respiratory function when compared to placebo and oxycodone
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Assessment method [7]
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Measured using pulse oximetry
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Timepoint [7]
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Up to 8 hours post dose
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Secondary outcome [8]
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Part 2: Effect of KUR-101 on respiratory function when compared to placebo and oxycodone
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Assessment method [8]
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Measured using vital signs monitoring
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Timepoint [8]
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Up to 8 hours post dose
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Secondary outcome [9]
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Part 2: Safety of KUR-101 when compared with placebo and oxycodone
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Assessment method [9]
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Measured by the incidence of treatment-emergent adverse events
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Timepoint [9]
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From the signing of the informed consent through Day 22
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Secondary outcome [10]
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Part 2: Addictive potential of KUR-101 when compared with placebo and oxycodone
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Assessment method [10]
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Measured through the Desire for Opioids visual acuity scale
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Timepoint [10]
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Up to 4 hours post dose
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Secondary outcome [11]
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Part 2: Addictive potential of KUR-101 when compared with placebo and oxycodone
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Assessment method [11]
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Measured through the Addiction Research Center Inventory Morphine Benzedrine Group scale
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Timepoint [11]
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Up to 4 hours post dose
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/02/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
12/10/2022
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Sample size
Target
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Accrual to date
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Final
60
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Christchurch
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Kures, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/study/NCT05114265
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05114265