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Completed

NCT Number: NCT04857957

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

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.

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Key information

Conditions

Painful Diabetic Neuropathy Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

AltaSciences

Overland Park, Kansas, 66212, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral dose CNTX-6016 or oral dose Placebo

Drug

CNTX-6016 or Placebo

Primary outcomes

  1. Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability) with CNTX-6016

    Time frame: Up to 45 days

    Number of participants with TEAEs, which includes laboratory test variables

  2. CNTX-6016 Pharmacokinetics - Cmax

    Time frame: Up to Day 6

    Systemic exposure to CNTX-6016 measured by Cmax

  3. CNTX-6016 Pharmacokinetics - AUC0-t

    Time frame: Up to Day 6

    Systemic exposure to CNTX-6016 measured by AUC0-t

  4. CNTX-6016 Pharmacokinetics - t1/2

    Time frame: Up to Day 6

    Systemic exposure to CNTX-6016 measured by t1/2

  5. CNTX-6016 Pharmacokinetics - tmax

    Time frame: Up to Day 6

    Systemic exposure to CNTX-6016 measured by tmax

Other outcomes

  1. CNTX-6016 Effect of Age and Sex in all Cohorts

    Time frame: Up to Day 14

    Systemic exposure to CNTX-6016 By Cmax pooled from all cohorts over full dose range.

  2. CNTX-6016 Effect of Age and Sex in all Cohorts

    Time frame: Up to Day 14

    Systemic exposure to CNTX-6016 By AUC pooled from all cohorts over full dose range.

  3. CNTX-6016 Efficacy - PDN Cohort

    Time frame: Up to Day 14

    Efficacy measured by Numeric Rating Scale. The Numeric Rating Scale is an 11-point pain scale with a range of 0 to 10 where 0 = "no pain" and 10 = "worst possible pain"

  4. CNTX-6016 Efficacy - PDN Cohort

    Time frame: Up to Day 14

    Efficacy measured by PainDETECT Questionnaire

  5. CNTX-6016 Efficacy - PDN Cohort

    Time frame: Up to Day 14

    Efficacy measured by Patient Global Impression of Change

Sponsors and collaborators

Lead sponsor

Centrexion Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 23, 2021
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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