Status:
COMPLETED
Safety, Tolerability & Pharmacokinetics Study of CNTX-6016 in Healthy Subjects and Subjects With PDN
Lead Sponsor:
Centrexion Therapeutics
Conditions:
Painful Diabetic Neuropathy
Eligibility:
All Genders
18-59 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
April 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2023
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04857957
Start Date
April 14 2021
End Date
August 30 2023
Last Update
July 28 2025
Active Locations (1)
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1
AltaSciences
Overland Park, Kansas, United States, 66212