Addiction
Conditions
Keywords
opioid use disorder (OUD)
Brief 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.
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.
Interventions
DRUG18-MC Compound
18-MC
Sponsors
Definium Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: 1. Written informed consent before any study-specific procedures. 2. Healthy male and female volunteers aged 18 to 55 years (inclusive) with suitable veins for cannulation and repeated venipuncture. 3. Female subjects of both childbearing and nonchildbearing potential will be considered, with certain conditions met 4. Female subjects must agree not to breastfeed starting at screening and throughout the study period. 5. Male participants must agree to practice abstinence; be surgically sterilized; or agree to use of a condom, plus effective contraception. 6. 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. Key
Exclusion criteria
1. 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 2. 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. 3. History of gastrointestinal ulcer disease, inflammatory bowel disease, or frequent indigestion symptoms 4. Adequate organ function 5. History of seizures or epilepsy. 6. Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV). 7. Any clinically significant cardiovascular abnormalities 8. Known or suspected history of substance abuse disorder 9. History of alcohol abuse or excessive intake of alcohol 10. Positive screen for drugs of abuse, cotinine (nicotine) or alcohol 11. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the safety, using incidence and severity of adverse events, of a single and multiple-day dosing of 18-MC administered orally. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | 48 post dose - Day 1 and Day 7 | Blood samples for determination of study drug (18-MC) concentration parameters at various timepoints |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | 48 hours post dose - Day 1 and Day 7 | Blood samples for determination of study drug (18-MC) parameters at various timepoints |
| Area Under the Curve from Time Zero to Last Quantifiable Concentration (AUClast) | AUC(t0-48hr) pg*hr/mL | Blood samples for determination of study drug (18-MC) parameters at various timepoints |
| Terminal Elimination Half-Life (t1/2) | 48 hours post dose - Day 1 and Day 7 | Blood samples for determination of study drug (18-MC) concentration parameters at various timepoints |
| As an exploratory objective, the concentration of metabolites in plasma and urine may be determined | Up to 28 days (SAD) and 42 days (MAD) | Plasma and urine samples for determination of study drug concentrations at various timepoints |
Countries
Australia
Outcome results
None listed