Safety, Tolerability & Pharmacokinetics Study of CNTX-6016 in Healthy Subjects and Subjects With PDN

Centrexion Therapeutics

Status and phase: Completed; Phase 1

Conditions: Painful Diabetic Neuropathy

Treatments: Drug: Oral dose CNTX-6016 or oral dose Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04857957

CNTX-6016o-HV/PDN-102

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 59 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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46 participants in 4 patient groups

Cohort 1

Experimental group

Description:

Dose 1

Treatment:

Drug: Oral dose CNTX-6016 or oral dose Placebo

Cohort 2

Experimental group

Description:

Dose 2

Treatment:

Drug: Oral dose CNTX-6016 or oral dose Placebo

Cohort 3

Experimental group

Description:

Dose 3

Treatment:

Drug: Oral dose CNTX-6016 or oral dose Placebo

PDN cohort

Experimental group

Description:

Dose based on safety in healthy Cohorts 1-3

Treatment:

Drug: Oral dose CNTX-6016 or oral dose Placebo