Chronic Pain, Nociceptive Pain
Conditions
Keywords
Chronic Pain, Nociceptive Pain, Mixed Pain
Brief summary
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.
Interventions
DRUGCNTX-6970
Oral dose CNTX-6970
OTHERPlacebo
Oral dose placebo
Sponsors
Centrexion Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Part 1: Open Label Part 2: Double-Blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CNTX-6970 Pharmacokinetics - t1/2 | Up to Day 13 | Systemic exposure to CNTX-6970 measured by t1/2 |
| CNTX-6970 Pharmacokinetics - AUC0-inf | Up to Day 13 | Systemic exposure to CNTX-6970 measured by AUC0-inf |
| CNTX-6970 Pharmacokinetics - Cmax | Up to Day 13 | Systemic exposure to CNTX-6970 measured by Cmax |
| CNTX-6970 Pharmacokinetics - tmax | Up to Day 13 | Systemic exposure to CNTX-6970 measured by tmax |
| CNTX-6970 Pharmacokinetics - fasted state or high-fat standardized meal | Up to Day 3 | Food effects on pharmacokinetics of CTNX-6790 for Part 1 participants |
| CNTX-6970 Pharmacokinetics - AUC0-t | Up to Day 13 | Systemic exposure to CNTX-6970 measured by AUC0-t |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CNTX-6970 Pharmacodynamics - Emax | Up to Day 13 | Pharmacodynamic effect on MCP-1 and RANTES measured by Emax |
| CNTX-6970 Pharmacodynamics - PD tmax | Up to Day 13 | Time to maximum pharmacodynamic effect on MCP-1 and RANTES measured by tmax |
| Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability) | Up to Day 13 | Number of participants with TEAEs, which includes laboratory test variables |
Countries
United States
Outcome results
None listed