A Placebo-Controlled, Two-Part Study, Oral Dose to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CNTX-6970 in Healthy Subjects

Study Overview
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Brief Summary
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A Phase 1, placebo-controlled, two part study with either single dose or multiple increasing oral dose to evaluate the safety, pharmacokinetics, and pharmacodynamics of CNTX-6970 in healthy subjects.

Official Title
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A Placebo-Controlled, Two-Part Study With Single Dose and Multiple Ascending Oral Dose to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CNTX-6970 in Healthy Subjects

Conditions
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Chronic Pain, Nociceptive Pain

Intervention / Treatment
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* Drug: CNTX-6970
* 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 the Investigator's review Has a body mass index (BMI) between 18 and 35kg/m^2, inclusive For females, is not currently pregnant or breastfeeding 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: Has a history of cardiac disease, including congestive heart failure, angina, or any arrhythmia Has diabetes mellitus, acromegaly, clinically active thyroid disease, or other active endocrinopathy 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) Has used within 14 days prior to the first admission or has plans to use during the study any over-the-counter medicinal products, including herbal and dietary supplements (except for occasional use of acetaminophen or NSAIDs, such as ibuprofen or naproxen; calcium; or Vitamin D) Use of any of the following: Human growth hormone, octreotide, anti-diabetic medication, or thyroid suppressors or supplements Immunosuppressive drugs within 30 days of study start, or 5 half-lives of the drug (whichever is longer), or plans to use during the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1 Cohort 1 (Single Dose)<br>Single 100 mg oral dose of CNTX-6970 (film-coated tablet or enteric-coated tablet) | Drug: CNTX-6970<br>* Oral dose CNTX-6970<br>|
| Experimental: Part 1 Cohort 2 (Single Dose)<br>Single 100 mg oral dose of CNTX-6970 film-coated tablet | Drug: CNTX-6970<br>* Oral dose CNTX-6970<br>|
| Experimental: Part 2 (Multiple Ascending Dose)<br>100 mg, 300 mg, and 600 mg CNTX-6970 oral tablet | Drug: CNTX-6970<br>* Oral dose CNTX-6970<br>|
| Placebo Comparator: Part 2 Placebo<br>Placebo oral tablet | Other: Placebo<br>* Oral dose placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CNTX-6970 Pharmacokinetics - fasted state or high-fat standardized meal | Food effects on pharmacokinetics of CTNX-6790 for Part 1 participants | Up to Day 3 | 
| CNTX-6970 Pharmacokinetics - AUC0-t | Systemic exposure to CNTX-6970 measured by AUC0-t | Up to Day 13 | 
| CNTX-6970 Pharmacokinetics - AUC0-inf | Systemic exposure to CNTX-6970 measured by AUC0-inf | Up to Day 13 | 
| CNTX-6970 Pharmacokinetics - Cmax | Systemic exposure to CNTX-6970 measured by Cmax | Up to Day 13 | 
| CNTX-6970 Pharmacokinetics - tmax | Systemic exposure to CNTX-6970 measured by tmax | Up to Day 13 | 
| CNTX-6970 Pharmacokinetics - t1/2 | Systemic exposure to CNTX-6970 measured by t1/2 | Up to Day 13 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability) | Number of participants with TEAEs, which includes laboratory test variables | Up to Day 13 | 
| CNTX-6970 Pharmacodynamics - Emax | Pharmacodynamic effect on MCP-1 and RANTES measured by Emax | Up to Day 13 | 
| CNTX-6970 Pharmacodynamics - PD tmax | Time to maximum pharmacodynamic effect on MCP-1 and RANTES measured by tmax | Up to Day 13 | 

 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