A Study to Evaluate the Safety and Pharmacokinetics of CNTX-6016 in Healthy Subjects

Study Overview
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Brief Summary
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A Phase 1 double-blind, placebo-controlled, randomized single ascending dose incorporating an open-label, 2-period crossover, food effect cohort.

Official Title
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A Study to Evaluate the Safety and Pharmacokinetics of Single Doses of CNTX-6016 in Healthy Subjects

Conditions
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Chronic Pain, Nociceptive Pain, Pain

Intervention / Treatment
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* Drug: CNTX-6016
* Other: Other: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Is in good general health as determined by Investigator's review. Has a body mass index (BMI) between 18 and 35 kg/m2. Non- or ex-smoker (> 1 year) and has not used any nicotine containing products within 12 months prior to screening. For females, is not currently pregnant and is either of non-childbearing potential or willing to use an adequate method of birth control. For males, must agree to use barrier contraception and not to donate sperm. Key Exclusion Criteria: History of or active cardiac disease, including congestive heart failure, angina, or any arrhythmia. Has any history or currently active type of cancer except excised or cured basal cell carcinoma. Has a gastrointestinal disorder that could interfere with the absorption of orally administered drugs. Has asthma or other severe respiratory disease (e.g., chronic obstructive pulmonary disease) requiring daily prescription medicine. Currently has kidney, neurologic, metabolic, or liver disease, or other organ system disease. Has a history, current evidence, or is being treated for depression, suicidal ideation, suicide attempt, or any other current psychiatric condition requiring active treatment. Has an immunological disorder such as, but not limited to, human immunodeficiency virus (HIV), acquired, or congenital immune deficiency syndrome; autoimmune diseases, such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, seronegative spondyloarthropathies or vasculitis, or any infection. Has positive screening test for hepatitis B virus (HBV) or hepatitis C virus (HCV). Is pregnant, lactating, or planning a pregnancy during the study. Has used any prescribed medication within 30 days prior to the first admission or has plans to use any prescribed medication during the study (with the exception of hormonal contraceptives). Positive urine screen for alcohol, cotinine, THC and/or drugs of abuse. Ingestion of food or beverages containing grapefruit and/or grapefruit juice and/or pomelos during the 7 days prior to dosing and/or during the study period.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Cohort 1 Placebo<br>Oral Placebo Capsule | Other: Other: Placebo<br>* Oral Dose Placebo<br>|
| Experimental: Cohort 1 Drug<br>25 mg Oral Capsule | Drug: CNTX-6016<br>* Oral Dose CNTX-6016<br>|
| Placebo Comparator: Cohort 2 Placebo<br>Oral Placebo Capsule | Other: Other: Placebo<br>* Oral Dose Placebo<br>|
| Experimental: Cohort 2 Drug<br>50 mg Oral Capsule | Drug: CNTX-6016<br>* Oral Dose CNTX-6016<br>|
| Placebo Comparator: Cohort 3 Placebo<br>Oral Placebo Capsule | Other: Other: Placebo<br>* Oral Dose Placebo<br>|
| Experimental: Cohort 3 Drug<br>100 mg Oral Capsule | Drug: CNTX-6016<br>* Oral Dose CNTX-6016<br>|
| Placebo Comparator: Cohort 4 Placebo<br>Oral Placebo Capsule | Other: Other: Placebo<br>* Oral Dose Placebo<br>|
| Experimental: Cohort 4 Drug<br>300 mg Oral Capsule | Drug: CNTX-6016<br>* Oral Dose CNTX-6016<br>|
| Placebo Comparator: Cohort 5 Placebo<br>Oral Placebo Capsule | Other: Other: Placebo<br>* Oral Dose Placebo<br>|
| Experimental: Cohort 5 Drug<br>450 mg Oral Capsule | Drug: CNTX-6016<br>* Oral Dose CNTX-6016<br>|
| Placebo Comparator: Cohort 6 Placebo<br>Oral Placebo Capsule | Other: Other: Placebo<br>* Oral Dose Placebo<br>|
| Experimental: Cohort 6 Drug<br>600 mg Oral Capsule | Drug: CNTX-6016<br>* Oral Dose CNTX-6016<br>|
| Placebo Comparator: Cohort 7 Placebo<br>Oral Placebo Capsule | Other: Other: Placebo<br>* Oral Dose Placebo<br>|
| Experimental: Cohort 7 Drug<br>800 mg Oral Capsule | Drug: CNTX-6016<br>* Oral Dose CNTX-6016<br>|
| Placebo Comparator: Cohort 9 Placebo<br>Oral Placebo Capsule | Other: Other: Placebo<br>* Oral Dose Placebo<br>|
| Experimental: Cohort 9 Drug<br>1000 mg Oral Capsule | Drug: CNTX-6016<br>* Oral Dose CNTX-6016<br>|
| Experimental: Cohort 8 Fasted<br>Participant will take 300 mg Oral Capsule in a fasting state, and then fed state. | Drug: CNTX-6016<br>* Oral Dose CNTX-6016<br>|
| Experimental: Cohort 8 Fed<br>Participant will take 300 mg Oral Capsule in a fed state, and then fasting state. | Drug: CNTX-6016<br>* Oral Dose CNTX-6016<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of single doses of CNTX-6016 - TEAEs | Information regarding treatment emergent adverse events was collected during each dose cohort. | Up to 80 days | 
| Dose Proportionality of a single doses of CNTX-6016 in healthy subjects | Dose Proportionality of a single doses of CNTX-6016 in healthy subjects. | 40 days | 
| CNTX-6016 Pharmacokinetics - Cmax | Systemic exposure to CNTX-6016 measured by Cmax. | Up to 40 days | 
| CNTX-6016 Pharmacokinetics - Tmax | Systemic exposure to CNTX-6016 measured by Tmax. | Up to 40 days | 
| CNTX-6016 Pharmacokinetics - t1/2 | Systemic exposure to CNTX-6016 measured by t1/2. | Up to 40 days | 
| CNTX-6016 Pharmacokinetics - AUC 0-t | Systemic exposure to CNTX-6016 measured by AUC 0-t. | Up to 40 days | 
| CNTX-6016 Pharmacokinetics - AUC 0-inf | Systemic exposure to CNTX-6016 measured by AUC 0-inf. | Up to 40 days | 
| CNTX-6016 Pharmacokinetics - AUC 0-t/inf | Systemic exposure to CNTX-6016 measured by AUC 0-t/inf. | Up to 40 days | 
| CNTX-6016 Pharmacokinetics - CL/F | Systemic exposure to CNTX-6016 measured by CL/F. | Up to 40 days | 
| CNTX-6016 Pharmacokinetics - Vz/F | Systemic exposure to CNTX-6016 measured by Vz/F. | Up to 40 days | 
| Effect of Gender on CNTX-6016 Pharmacokinetics - Cmax | Effect of Gender on the systemic exposure to CNTX-6016 measured by Cmax. | Up to 80 days | 
| Effect of Gender on CNTX-6016 Pharmacokinetics - Tmax | Effect of Gender on the systemic exposure to CNTX-6016 measured by tmax. | Up to 80 days | 
| Effect of Gender on CNTX-6016 Pharmacokinetics - t1/2 | Effect of Gender on the systemic exposure to CNTX-6016 measured by t1/2 | Up to 80 days | 
| Effect of Gender on CNTX-6016 Pharmacokinetics - AUC | Effect of Gender on the systemic exposure to CNTX-6016 measured by AUC. | Up to 80 days | 
| Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - Cmax | Systemic exposure to CNTX-6016 in fasted or fed state as measured by Cmax | Up to 40 days | 
| Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - Tmax | Systemic exposure to CNTX-6016 in fasted or fed state as measured by Tmax | Up to 40 days | 
| Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - t1/2 | Systemic exposure to CNTX-6016 in fasted or fed state as measured by t1/2 | Up to 40 days | 
| Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - AUC | Systemic exposure to CNTX-6016 in fasted or fed state as measured by AUC | Up to 40 days | 
| Urinary Excretion | Urine was collected over a 3-day period (0-72 hrs) in Cohort 8 and analyzed for concentrations of CNTX-6016 in subjects in both the fasted and fed states using Liquid Chromatography Mass Spectrometry. | Up to 6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma and Urine Metabolite Mining | Urine was collected over a 3-day period (0-72hrs) in Cohort 9 (1000mg) and analyzed for concentrations of parent and metabolites of CNTX-6016 using Liquid Chromatography Mass Spectrometry. | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Pain, Nociceptive Pain, Mixed Pain, Cannabinoid, Cannabinoid-2 Receptor Agonist