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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05114265




Registration number
NCT05114265
Ethics application status
Date submitted
19/10/2021
Date registered
9/11/2021
Date last updated
14/12/2022

Titles & IDs
Public title
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of KUR-101 in Healthy Adults
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
Secondary ID [1] 0 0
KUR-101-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Pain 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1: Safety of KUR-101 when compared with placebo
Timepoint [1] 0 0
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 outcome [2] 0 0
Part 2: Effect of KUR-101 on evoked pain response as compared to oxycodone and placebo
Timepoint [2] 0 0
Up to 4 hours post dose
Primary outcome [3] 0 0
Part 2: Effect of KUR-101 on evoked pain response as compared to oxycodone and placebo
Timepoint [3] 0 0
Up to 4 hours post dose
Secondary outcome [1] 0 0
Part 1 and Part 2: Pharmacokinetics of KUR-101
Timepoint [1] 0 0
Up to 48 hours post dose
Secondary outcome [2] 0 0
Part 1: Pharmacokinetics of KUR-101
Timepoint [2] 0 0
Up to 48 hours post dose
Secondary outcome [3] 0 0
Part 1: Effect of KUR-101 on respiratory function when compared to placebo
Timepoint [3] 0 0
Up to 8 hours post dose
Secondary outcome [4] 0 0
Part 1: Effect of KUR-101 on respiratory function when compared to placebo
Timepoint [4] 0 0
Up to 8 hours post dose
Secondary outcome [5] 0 0
Part 1: Effect of KUR-101 on respiratory function when compared to placebo
Timepoint [5] 0 0
Up to 8 hours post dose
Secondary outcome [6] 0 0
Part 2: Effect of KUR-101 on respiratory function when compared to placebo and oxycodone
Timepoint [6] 0 0
Up to 8 hours post dose
Secondary outcome [7] 0 0
Part 2: Effect of KUR-101 on respiratory function when compared to placebo and oxycodone
Timepoint [7] 0 0
Up to 8 hours post dose
Secondary outcome [8] 0 0
Part 2: Effect of KUR-101 on respiratory function when compared to placebo and oxycodone
Timepoint [8] 0 0
Up to 8 hours post dose
Secondary outcome [9] 0 0
Part 2: Safety of KUR-101 when compared with placebo and oxycodone
Timepoint [9] 0 0
From the signing of the informed consent through Day 22
Secondary outcome [10] 0 0
Part 2: Addictive potential of KUR-101 when compared with placebo and oxycodone
Timepoint [10] 0 0
Up to 4 hours post dose
Secondary outcome [11] 0 0
Part 2: Addictive potential of KUR-101 when compared with placebo and oxycodone
Timepoint [11] 0 0
Up to 4 hours post dose

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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/10/2022
Sample size
Target
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Kures, Inc.
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05114265
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries