AddictionPhase 1NCT04292197
A Study to Assess 18-Methoxycoronaridine (18-MC HCl) in Healthy Volunteers
A Phase 1 study testing 18-MC Compound in people with Addiction, run by Definium Therapeutics US, Inc. at 1 site in Australia.
Trial summary
The primary objective of this study is to assess the safety and tolerability of a single day dosing and a separate multiple day dosing of 18-MC HCl administered orally, each part of the study having a different set of healthy male and female volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Addiction
- What is being tested?
- 18-MC Compound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteAustralia
- Study dates
- 14 Apr 2020to 31 Dec 2021
- 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
- Written informed consent before any study-specific procedures.
- Healthy male and female volunteers aged 18 to 55 years (inclusive) with suitable veins for cannulation and repeated venipuncture.
- Female subjects of both childbearing and nonchildbearing potential will be considered, with certain conditions met
- Female subjects must agree not to breastfeed starting at screening and throughout the study period.
- Male participants must agree to practice abstinence; be surgically sterilized; or agree to use of a condom, plus effective contraception.
- Have not smoked or used any tobacco or nicotine-containing products in the 3 months before screening and agree not to smoke during the entire study.
Who cannot join
- History of any clinically important disease or disorder that, in the opinion of the investigator, would affect the ability of the participant to participate in the study
- History or presence of gastrointestinal, hepatic, cardiac, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of study drug.
- History of gastrointestinal ulcer disease, inflammatory bowel disease, or frequent indigestion symptoms
- Adequate organ function
- History of seizures or epilepsy.
- Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV).
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- Any clinically significant cardiovascular abnormalities
- Known or suspected history of substance abuse disorder
- History of alcohol abuse or excessive intake of alcohol
- Positive screen for drugs of abuse, cotinine (nicotine) or alcohol
- Has received another new chemical entity (defined as a compound, which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Single/Multiple Day Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of 18- Methoxycoronaridine (18-MC HCl) Administered Orally to Normal Healthy Volunteers
The primary objective of this study is to assess the safety and tolerability of a single day dosing and a separate multiple day dosing of 18-MC HCl administered orally, each part of the study having a different set of healthy male and female volunteers.
Read the detailed description
This is a Phase 1, double-blind, randomized, placebo-controlled, single day and multiple day dosing, in healthy, non-smoking, male and female volunteers.
Part 1: Single Ascending Dose (SAD)
Seven (7) healthy male and female volunteers will be randomly assigned to receive either 18-MC HCl (n=5) or placebo (n=2) in each cohort. These volunteers will receive 18-MC HCl twice in 1 day (bid).
There are 3 phases: Screening, Enrollment and Follow-Up. All participants will be assessed for safety and tolerability for 28 days. Screening begins when a participant reports to the clinical unit (CU) for a screening visit to undergo safety and compliance assessments on this day. Participants that meet all eligibility criteria will be admitted to the CU on the day prior to receiving study drug. Enrollment begins on Day 1 where participants will receive two doses of study drug for 1 day, will be assessed for 18-MC PK up to 48 hours, and will remain admitted at the CU until Day 3, at which time they will be discharged. For follow-up the participants will return for safety and tolerability assessments at Days 7, 14, 21 and Day 28.
Part 2: Multiple Day Ascending Dose (MAD)
Seven (7) healthy male and female volunteers will be randomly assigned to receive either 18-MC HCl (n=5) or placebo (n=2) in each cohort. These volunteers will receive 18-MC HCl twice over 7 days (bid).
There are 3 phases: Screening, Enrollment and Follow-Up. All participants will be assessed for 42 days. Screening begins when a participant reports to the clinical unit (CU) for a screening visit to undergo safety and compliance assessments on this day. Participants that meet all eligibility criteria will be admitted to the CU on the day prior to receiving study drug. Enrollment begins on Day 1 where participants will receive two doses of study drug every day for 7 days, will be assessed for 18-MC PK up to 48 hours on Day 1 and Day 7, and will remain admitted at the CU until Day 9, at which time they will be discharged. For follow-up the participants will return for safety and tolerability assessments at Days 14, 21, 28, 35 and Day 42.
- Conditions
- Addiction
- Being tested
- 18-MC Compound
- Keywords
- opioid use disorder (OUD)
- Medical subject headings
- Behavior, Addictive, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18-MC CompoundDrug
18-MC
| Study group | Role | What they receive |
|---|---|---|
| 18-MC SAD Study | Experimental | In Part 1, healthy participants will be randomized into cohorts to receive 18-MC HCl or placebo twice in 1 day. Receives: Drug: 18-MC Compound |
| 18-MC MAD Study | Experimental | In Part 2, healthy participants will be randomized into cohorts to receive 18-MC HCl or placebo twice a day for 7 consecutive days. Receives: Drug: 18-MC Compound |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety, using incidence and severity of adverse events, of a single and multiple-day dosing of 18-MC administered orally.
Safety and tolerability will be assessed by the incidence and severity of adverse events (AEs). An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.
Measured: Up to 28 days (SAD) and 42 days (MAD)
Secondary outcomes (5)
Maximum Observed Plasma Concentration (Cmax)
Blood samples for determination of study drug (18-MC) concentration parameters at various timepoints
Measured: 48 post dose - Day 1 and Day 7
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Blood samples for determination of study drug (18-MC) parameters at various timepoints
Measured: 48 hours post dose - Day 1 and Day 7
Area Under the Curve from Time Zero to Last Quantifiable Concentration (AUClast)
Blood samples for determination of study drug (18-MC) parameters at various timepoints
Measured: AUC(t0-48hr) pg*hr/mL
Terminal Elimination Half-Life (t1/2)
Blood samples for determination of study drug (18-MC) concentration parameters at various timepoints
Measured: 48 hours post dose - Day 1 and Day 7
As an exploratory objective, the concentration of metabolites in plasma and urine may be determined
Plasma and urine samples for determination of study drug concentrations at various timepoints
Measured: Up to 28 days (SAD) and 42 days (MAD)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start14 Apr 2020
- Primary completion13 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AddictionStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Definium Therapeutics US, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292197
- Sponsor's protocol ID
- MMED003
- Status last verified
- Jan 2022
- First submitted
- 18 Feb 2020
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Single/Multiple Day Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of 18- Methoxycoronaridine (18-MC HCl) Administered Orally to Normal Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04292197
- Acronym / sponsor ID
- MMED003
- Conditions
- Addiction
- Keywords
- opioid use disorder (OUD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Definium Therapeutics US, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Apr 2020 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 3 Mar 2020 (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.
The primary objective of this study is to assess the safety and tolerability of a single day dosing and a separate multiple day dosing of 18-MC HCl administered orally, each part of the study having a different set of healthy male and female volunteers.
Detailed description
This is a Phase 1, double-blind, randomized, placebo-controlled, single day and multiple day dosing, in healthy, non-smoking, male and female volunteers.
Part 1: Single Ascending Dose (SAD)
Seven (7) healthy male and female volunteers will be randomly assigned to receive either 18-MC HCl (n=5) or placebo (n=2) in each cohort. These volunteers will receive 18-MC HCl twice in 1 day (bid).
There are 3 phases: Screening, Enrollment and Follow-Up. All participants will be assessed for safety and tolerability for 28 days. Screening begins when a participant reports to the clinical unit (CU) for a screening visit to undergo safety and compliance assessments on this day. Participants that meet all eligibility criteria will be admitted to the CU on the day prior to receiving study drug. Enrollment begins on Day 1 where participants will receive two doses of study drug for 1 day, will be assessed for 18-MC PK up to 48 hours, and will remain admitted at the CU until Day 3, at which time they will be discharged. For follow-up the participants will return for safety and tolerability assessments at Days 7, 14, 21 and Day 28.
Part 2: Multiple Day Ascending Dose (MAD)
Seven (7) healthy male and female volunteers will be randomly assigned to receive either 18-MC HCl (n=5) or placebo (n=2) in each cohort. These volunteers will receive 18-MC HCl twice over 7 days (bid).
There are 3 phases: Screening, Enrollment and Follow-Up. All participants will be assessed for 42 days. Screening begins when a participant reports to the clinical unit (CU) for a screening visit to undergo safety and compliance assessments on this day. Participants that meet all eligibility criteria will be admitted to the CU on the day prior to receiving study drug. Enrollment begins on Day 1 where participants will receive two doses of study drug every day for 7 days, will be assessed for 18-MC PK up to 48 hours on Day 1 and Day 7, and will remain admitted at the CU until Day 9, at which time they will be discharged. For follow-up the participants will return for safety and tolerability assessments at Days 14, 21, 28, 35 and Day 42.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 18-MC SAD Study | Experimental | Drug: 18-MC CompoundIn Part 1, healthy participants will be randomized into cohorts to receive 18-MC HCl or placebo twice in 1 day. |
| 18-MC MAD Study | Experimental | Drug: 18-MC CompoundIn Part 2, healthy participants will be randomized into cohorts to receive 18-MC HCl or placebo twice a day for 7 consecutive days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Written informed consent before any study-specific procedures.
- Healthy male and female volunteers aged 18 to 55 years (inclusive) with suitable veins for cannulation and repeated venipuncture.
- Female subjects of both childbearing and nonchildbearing potential will be considered, with certain conditions met
- Female subjects must agree not to breastfeed starting at screening and throughout the study period.
- Male participants must agree to practice abstinence; be surgically sterilized; or agree to use of a condom, plus effective contraception.
Key exclusion criteria (11 listed)
- History of any clinically important disease or disorder that, in the opinion of the investigator, would affect the ability of the participant to participate in the study
- History or presence of gastrointestinal, hepatic, cardiac, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of study drug.
- History of gastrointestinal ulcer disease, inflammatory bowel disease, or frequent indigestion symptoms
- Adequate organ function
- History of seizures or epilepsy.
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 |
|---|---|---|
| 18-MC Compound18-MC | Drug | 18-MC MAD Study, 18-MC SAD Study |
Primary outcome
To assess the safety, using incidence and severity of adverse events, of a single and multiple-day dosing of 18-MC administered orally.
Time frame: Up to 28 days (SAD) and 42 days (MAD)
Safety and tolerability will be assessed by the incidence and severity of adverse events (AEs). An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.
5 secondary outcomes
Maximum Observed Plasma Concentration (Cmax)
Time frame: 48 post dose - Day 1 and Day 7
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 48 hours post dose - Day 1 and Day 7
Area Under the Curve from Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: AUC(t0-48hr) pg*hr/mL
Terminal Elimination Half-Life (t1/2)
Time frame: 48 hours post dose - Day 1 and Day 7
As an exploratory objective, the concentration of metabolites in plasma and urine may be determined
Time frame: Up to 28 days (SAD) and 42 days (MAD)
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 5 Jan 2022.
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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 18-MC Compound in people with Addiction, run by Definium Therapeutics US, Inc. at 1 site in Australia.
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 6 inclusion and 11 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 5 Jan 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 Australia. 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?
To assess the safety, using incidence and severity of adverse events, of a single and multiple-day dosing of 18-MC administered orally. (time frame: Up to 28 days (SAD) and 42 days (MAD)). 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 5 Jan 2022.