Clinical trial NCT04857957: Safety, Tolerability & Pharmacokinetics Study of CNTX-6016 in Healthy Subjects and Subjects With PDN
Official title: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CNTX-6016 in Healthy Subjects and a Single Cohort of Subjects With Painful Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Painful Diabetic Neuropathy
Keywords: Painful Diabetic Neuropathy
Lead sponsor: Centrexion Therapeutics
Sponsor class: INDUSTRY
First posted: 2021-04-23
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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: 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

Primary outcomes:
measure: Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability) with CNTX-6016
timeFrame: Up to 45 days
measure: CNTX-6016 Pharmacokinetics - Cmax
timeFrame: Up to Day 6
measure: CNTX-6016 Pharmacokinetics - AUC0-t
timeFrame: Up to Day 6
measure: CNTX-6016 Pharmacokinetics - t1/2
timeFrame: Up to Day 6
measure: CNTX-6016 Pharmacokinetics - tmax
timeFrame: Up to Day 6
Secondary outcomes:
Other outcomes:
measure: CNTX-6016 Effect of Age and Sex in all Cohorts
timeFrame: Up to Day 14
measure: CNTX-6016 Effect of Age and Sex in all Cohorts
timeFrame: Up to Day 14
measure: CNTX-6016 Efficacy - PDN Cohort
timeFrame: Up to Day 14
measure: CNTX-6016 Efficacy - PDN Cohort
timeFrame: Up to Day 14
measure: CNTX-6016 Efficacy - PDN Cohort
timeFrame: Up to Day 14
Locations:
city: Overland Park
country: United States
facility: AltaSciences
state: Kansas
Study officials:
affiliation: Centrexion Therapeutics
name: Randall Stevens, MD
role: STUDY_CHAIR
References: