A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of KUR-101 in Healthy Adults

NCT05114265 | Completed Phase 1

• 1 other identifier: KUR-101-101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (11)

• Part 1 and Part 2: Pharmacokinetics of KUR-101

  Up to 48 hours post dose

• Part 1: Pharmacokinetics of KUR-101

  Up to 48 hours post dose

• Part 1: Effect of KUR-101 on respiratory function when compared to placebo

  Up to 8 hours post dose

• Part 1: Effect of KUR-101 on respiratory function when compared to placebo

  Up to 8 hours post dose

• Part 1: Effect of KUR-101 on respiratory function when compared to placebo

  Up to 8 hours post dose

Other Outcomes (3)

• Part 1: Effect of KUR-101 on evoked pain response as compared to placebo

  Day 1 up to 4 hours post dose

• Part 1: Addictive potential of KUR-101 when compared with placebo

  Up to 4 hours post dose

• Part 1: Addictive potential of KUR-101 when compared with placebo

  Up to 4 hours post dose

Study Arms (2)

Part 1: Single ascending dose

EXPERIMENTAL

Single dose of oral KUR-101 or oral placebo

Drug: KUR-101; Drug: Placebo

Part 2: Three-way crossover

EXPERIMENTAL

Single dose of oral KUR-101, oral placebo and oral OxyNorm

Drug: KUR-101; Drug: OxyNorm; Drug: Placebo

Interventions

KUR-101 DRUG

Single oral dose of KUR-101

Part 1: Single ascending dose; Part 2: Three-way crossover

OxyNorm DRUG

Single oral dose of OxyNorm

Part 2: Three-way crossover

Placebo DRUG

Single oral dose of placebo

Part 1: Single ascending dose; Part 2: Three-way crossover

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kures, Inc.: lead

Study Sites (1)

KUR-101-101 Clinical Research Site

Christchurch, 8011, New Zealand

Location

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: November 9, 2021
• Study Start: February 15, 2022
• Primary Completion: October 12, 2022
• Study Completion: October 12, 2022
• Last Updated: December 14, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)