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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 Cohort 1 (Single Dose) | Experimental | Single 100 mg oral dose of CNTX-6970 (film-coated tablet or enteric-coated tablet) |
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| Part 1 Cohort 2 (Single Dose) | Experimental | Single 100 mg oral dose of CNTX-6970 film-coated tablet |
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| Part 2 (Multiple Ascending Dose) | Experimental | 100 mg, 300 mg, and 600 mg CNTX-6970 oral tablet |
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| Part 2 Placebo | Placebo Comparator | Placebo oral tablet |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CNTX-6970 | Drug | Oral dose CNTX-6970 |
|
| 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 |
| 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 |
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Key Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Randall M. Stevens, MD | Centrexion Therapeutics | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medpace Clinical Pharmacology Unit | Cincinnati | Ohio | 45227 | United States |
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Part 1: Open Label Part 2: Double-Blind
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| Placebo | Other | Oral dose placebo |
|
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 |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D059226 | Nociceptive Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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