Safety, Tolerability & Pharmacokinetics Study of CNTX-6016 in Healthy Subjects and Subjects With PDN
Phase 1
Completed
- Conditions
- Painful Diabetic Neuropathy
- Interventions
- Drug: Oral dose CNTX-6016 or oral dose Placebo
- Registration Number
- NCT04857957
- Lead Sponsor
- Centrexion Therapeutics
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 3 Oral dose CNTX-6016 or oral dose Placebo 800 mg oral dose TID Cohort 1 Oral dose CNTX-6016 or oral dose Placebo 300 mg oral dose TID Cohort 2 Oral dose CNTX-6016 or oral dose Placebo 600 mg oral dose TID PDN cohort Oral dose CNTX-6016 or oral dose Placebo Dose based on safety in healthy Cohorts 1-3
- Primary Outcome Measures
Name Time Method 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
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
CNTX-6016 Pharmacokinetics - tmax Up to Day 6 Systemic exposure to CNTX-6016 measured by tmax
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
AltaSciences
🇺🇸Overland Park, Kansas, United States