Safety, Tolerability & Pharmacokinetics Study of CNTX-6016 in Healthy Subjects and Subjects With PDN
NCT ID: NCT04857957
Last Updated: 2025-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
46 participants
INTERVENTIONAL
2021-04-14
2023-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cohort 1
Dose 1
Oral dose CNTX-6016 or oral dose Placebo
CNTX-6016 or Placebo
Cohort 2
Dose 2
Oral dose CNTX-6016 or oral dose Placebo
CNTX-6016 or Placebo
Cohort 3
Dose 3
Oral dose CNTX-6016 or oral dose Placebo
CNTX-6016 or Placebo
PDN cohort
Dose based on safety in healthy Cohorts 1-3
Oral dose CNTX-6016 or oral dose Placebo
CNTX-6016 or Placebo
Interventions
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Oral dose CNTX-6016 or oral dose Placebo
CNTX-6016 or Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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).
* 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
18 Years
59 Years
ALL
Yes
Sponsors
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Centrexion Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Randall Stevens, MD
Role: STUDY_CHAIR
Centrexion Therapeutics
Locations
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AltaSciences
Overland Park, Kansas, United States
Countries
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Other Identifiers
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CNTX-6016o-HV/PDN-102
Identifier Type: -
Identifier Source: org_study_id
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