Acute PainPhase 1NCT05114265
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of KUR-101 in Healthy Adults
A Phase 1 study testing KUR-101 and OxyNorm in people with Acute Pain, run by Kures, Inc. at 1 site in New Zealand.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Pain
- What is being tested?
- KUR-101 and OxyNorm
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteNew Zealand
- Study dates
- 15 Feb 2022to 12 Oct 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read more
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.
Read the detailed 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.
- Conditions
- Acute Pain
- Being tested
- KUR-101, OxyNorm, Placebo
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KUR-101Drug
Single oral dose of KUR-101
OxyNormDrug
Single oral dose of OxyNorm
PlaceboDrug
Single oral dose of placebo
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Single ascending dose | Experimental | Single dose of oral KUR-101 or oral placebo Receives: Drug: KUR-101; Drug: Placebo |
| Part 2: Three-way crossover | Experimental | Single dose of oral KUR-101, oral placebo and oral OxyNorm Receives: Drug: KUR-101; Drug: OxyNorm; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Safety of KUR-101 when compared with placebo
Measured by the incidence of treatment-emergent adverse events
Measured: From the signing of the informed consent through Day 8 in Cohort 1, 2, 4 and 5 and through Day 15 in Cohort 3
Part 2: Effect of KUR-101 on evoked pain response as compared to oxycodone and placebo
Measured using the cold pressor test
Measured: Up to 4 hours post dose
Part 2: Effect of KUR-101 on evoked pain response as compared to oxycodone and placebo
Measured using thermal sensory testing
Measured: Up to 4 hours post dose
Secondary outcomes (11)
Part 1 and Part 2: Pharmacokinetics of KUR-101
Measured by levels of KUR-101 in the blood
Measured: Up to 48 hours post dose
Part 1: Pharmacokinetics of KUR-101
Measured by levels of KUR-101 in the urine
Measured: Up to 48 hours post dose
Part 1: Effect of KUR-101 on respiratory function when compared to placebo
Measured using continuous end-tidal capnography monitoring
Measured: Up to 8 hours post dose
Part 1: Effect of KUR-101 on respiratory function when compared to placebo
Measured using pulse oximetry
Measured: Up to 8 hours post dose
Part 1: Effect of KUR-101 on respiratory function when compared to placebo
Measured using vital signs monitoring
Measured: Up to 8 hours post dose
Part 2: Effect of KUR-101 on respiratory function when compared to placebo and oxycodone
Measured using continuous end-tidal capnography monitoring
Measured: Up to 8 hours post dose
Part 2: Effect of KUR-101 on respiratory function when compared to placebo and oxycodone
Measured using pulse oximetry
Measured: Up to 8 hours post dose
Part 2: Effect of KUR-101 on respiratory function when compared to placebo and oxycodone
Measured using vital signs monitoring
Measured: Up to 8 hours post dose
Part 2: Safety of KUR-101 when compared with placebo and oxycodone
Measured by the incidence of treatment-emergent adverse events
Measured: From the signing of the informed consent through Day 22
Part 2: Addictive potential of KUR-101 when compared with placebo and oxycodone
Measured through the Desire for Opioids visual acuity scale
Measured: Up to 4 hours post dose
Part 2: Addictive potential of KUR-101 when compared with placebo and oxycodone
Measured through the Addiction Research Center Inventory Morphine Benzedrine Group scale
Measured: Up to 4 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start15 Feb 2022
- Primary completion12 Oct 2022
- Study completion12 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kures, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05114265
- Sponsor's protocol ID
- KUR-101-101
- Status last verified
- Dec 2022
- First submitted
- 19 Oct 2021
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05114265
- Acronym / sponsor ID
- KUR-101-101
- Conditions
- Acute Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kures, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 12 Oct 2022 (actual)
- Study completion
- 12 Oct 2022 (actual)
- First posted
- 9 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: Single ascending dose | Experimental | Drug: KUR-101, Drug: PlaceboSingle dose of oral KUR-101 or oral placebo |
| Part 2: Three-way crossover | Experimental | Drug: KUR-101, Drug: OxyNorm, Drug: PlaceboSingle dose of oral KUR-101, oral placebo and oral OxyNorm |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KUR-101Single oral dose of KUR-101 | Drug | Part 1: Single ascending dose, Part 2: Three-way crossover |
| OxyNormSingle oral dose of OxyNorm | Drug | Part 2: Three-way crossover |
| PlaceboSingle oral dose of placebo | Drug | Part 1: Single ascending dose, Part 2: Three-way crossover |
Primary outcome
Part 1: Safety of KUR-101 when compared with placebo
Time frame: From the signing of the informed consent through Day 8 in Cohort 1, 2, 4 and 5 and through Day 15 in Cohort 3
Measured by the incidence of treatment-emergent adverse events
Part 2: Effect of KUR-101 on evoked pain response as compared to oxycodone and placebo
Time frame: Up to 4 hours post dose
Measured using the cold pressor test
Part 2: Effect of KUR-101 on evoked pain response as compared to oxycodone and placebo
Time frame: Up to 4 hours post dose
Measured using thermal sensory testing
11 secondary outcomes
Part 1 and Part 2: Pharmacokinetics of KUR-101
Time frame: Up to 48 hours post dose
Part 1: Pharmacokinetics of KUR-101
Time frame: Up to 48 hours post dose
Part 1: Effect of KUR-101 on respiratory function when compared to placebo
Time frame: Up to 8 hours post dose
Part 1: Effect of KUR-101 on respiratory function when compared to placebo
Time frame: Up to 8 hours post dose
Part 1: Effect of KUR-101 on respiratory function when compared to placebo
Time frame: Up to 8 hours post dose
Part 2: Effect of KUR-101 on respiratory function when compared to placebo and oxycodone
Time frame: Up to 8 hours post dose
Part 2: Effect of KUR-101 on respiratory function when compared to placebo and oxycodone
Time frame: Up to 8 hours post dose
Part 2: Effect of KUR-101 on respiratory function when compared to placebo and oxycodone
Time frame: Up to 8 hours post dose
Part 2: Safety of KUR-101 when compared with placebo and oxycodone
Time frame: From the signing of the informed consent through Day 22
Part 2: Addictive potential of KUR-101 when compared with placebo and oxycodone
Time frame: Up to 4 hours post dose
Part 2: Addictive potential of KUR-101 when compared with placebo and oxycodone
Time frame: Up to 4 hours post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KUR-101 and OxyNorm in people with Acute Pain, run by Kures, Inc. at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Safety of KUR-101 when compared with placebo (time frame: From the signing of the informed consent through Day 8 in Cohort 1, 2, 4 and 5 and through Day 15 in Cohort 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2022.