Safety, Tolerability & Pharmacokinetics Study of CNTX-6016 in Healthy Subjects and Subjects With PDN

Study Overview
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Brief Summary
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A Phase 1b study to evaluate the safety, tolerability and pharmacokinetics of multiple ascending doses of CNTX-6016 in healthy subjects and a single cohort to evaluate painful diabetic neuropathy.

Official Title
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A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CNTX-6016 in Healthy Subjects and a Single Cohort of Subjects With Painful Diabetic Neuropathy

Conditions
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Painful Diabetic Neuropathy

Intervention / Treatment
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* Drug: Oral dose CNTX-6016 or oral dose 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: Is pregnant, lactating, or planning a pregnancy during the study. Tests positive for COVID-19 after screening is complete and subject is confirmed to enroll 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 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. Positive urine screen for alcohol, cotinine, THC and/or drugs of abuse Has positive screening test for hepatitis B virus (HBV) or hepatitis C virus (HCV). Key Inclusion Criteria- PDN Cohort A diagnosis/history of Type 2 diabetes mellitus The pain is present in both feet/legs with symmetrical onset The pain is characterized as burning, painful, cold or electrical shocks in nature The pain is associated with tingling, numbness, itching or pins and needles type sensations The pain has been present and consistent for ≥ 6 months Key Exclusion Criteria- PDN Cohort Diagnosis of Type 1 diabetes Has serious or unstable cardiovascular, hepatic, renal, respiratory or hematological illness Has a history or currently active type of cancer except excised or cured basal cell carcinoma. Has a History of psychological conditions or neurological disorders Has a History of lower back pain with radiculopathy Has received non-pharmacological treatment for pain within 14 days Has a history of frequent and/or severe allergic reactions with multiple medications

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>300 mg oral dose TID | Drug: Oral dose CNTX-6016 or oral dose Placebo<br>* CNTX-6016 or Placebo<br>|
| Experimental: Cohort 2<br>600 mg oral dose TID | Drug: Oral dose CNTX-6016 or oral dose Placebo<br>* CNTX-6016 or Placebo<br>|
| Experimental: Cohort 3<br>800 mg oral dose TID | Drug: Oral dose CNTX-6016 or oral dose Placebo<br>* CNTX-6016 or Placebo<br>|
| Experimental: PDN cohort<br>Dose based on safety in healthy Cohorts 1-3 | Drug: Oral dose CNTX-6016 or oral dose Placebo<br>* CNTX-6016 or Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability) with CNTX-6016 | Number of participants with TEAEs, which includes laboratory test variables | Up to 45 days | 
| CNTX-6016 Pharmacokinetics - Cmax | Systemic exposure to CNTX-6016 measured by Cmax | Up to Day 6 | 
| CNTX-6016 Pharmacokinetics - AUC0-t | Systemic exposure to CNTX-6016 measured by AUC0-t | Up to Day 6 | 
| CNTX-6016 Pharmacokinetics - t1/2 | Systemic exposure to CNTX-6016 measured by t1/2 | Up to Day 6 | 
| CNTX-6016 Pharmacokinetics - tmax | Systemic exposure to CNTX-6016 measured by tmax | Up to Day 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Painful Diabetic Neuropathy