Painful Diabetic Neuropathy
Conditions
Keywords
Painful Diabetic Neuropathy
Brief summary
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.
Interventions
DRUGOral dose CNTX-6016 or oral dose Placebo
CNTX-6016 or Placebo
Sponsors
Centrexion Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CNTX-6016 Pharmacokinetics - Cmax | Up to Day 6 | Systemic exposure to CNTX-6016 measured by Cmax |
| CNTX-6016 Pharmacokinetics - t1/2 | Up to Day 6 | Systemic exposure to CNTX-6016 measured by t1/2 |
| CNTX-6016 Pharmacokinetics - tmax | Up to Day 6 | Systemic exposure to CNTX-6016 measured by tmax |
| Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability) with CNTX-6016 | Up to 45 days | Number of participants with TEAEs, which includes laboratory test variables |
| CNTX-6016 Pharmacokinetics - AUC0-t | Up to Day 6 | Systemic exposure to CNTX-6016 measured by AUC0-t |
Other
| Measure | Time frame | Description |
|---|---|---|
| CNTX-6016 Efficacy - PDN Cohort | Up to Day 14 | Efficacy measured by Numeric Rating Scale. The Numeric Rating Scale is an 11-point pain scale with a range of 0 to 10 where 0 = no pain and 10 = worst possible pain |
| CNTX-6016 Effect of Age and Sex in all Cohorts | Up to Day 14 | Systemic exposure to CNTX-6016 By Cmax pooled from all cohorts over full dose range. |
Countries
United States
Outcome results
None listed