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

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

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.

Study Overview

• Status: Completed
• Conditions: Painful Diabetic Neuropathy
• Intervention / Treatment: Drug: Oral dose CNTX-6016 or oral dose Placebo

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Study manager; Phone Number: 617-837-6911; Email: info@centrexion.com

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Altasciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 57 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; 300 mg oral dose TID	Drug: Oral dose CNTX-6016 or oral dose Placebo; CNTX-6016 or Placebo
Experimental: Cohort 2; 600 mg oral dose TID	Drug: Oral dose CNTX-6016 or oral dose Placebo; CNTX-6016 or Placebo
Experimental: Cohort 3; 800 mg oral dose TID	Drug: Oral dose CNTX-6016 or oral dose Placebo; CNTX-6016 or Placebo
Experimental: PDN cohort; Dose based on safety in healthy Cohorts 1-3	Drug: Oral dose CNTX-6016 or oral dose Placebo; CNTX-6016 or Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability) with CNTX-6016	Number of participants with TEAEs, which includes laboratory test variables	Up to 45 days
CNTX-6016 Pharmacokinetics - Cmax	Systemic exposure to CNTX-6016 measured by Cmax	Up to Day 6
CNTX-6016 Pharmacokinetics - AUC0-t	Systemic exposure to CNTX-6016 measured by AUC0-t	Up to Day 6
CNTX-6016 Pharmacokinetics - t1/2	Systemic exposure to CNTX-6016 measured by t1/2	Up to Day 6
CNTX-6016 Pharmacokinetics - tmax	Systemic exposure to CNTX-6016 measured by tmax	Up to Day 6

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
CNTX-6016 Effect of Age and Sex in all Cohorts	Systemic exposure to CNTX-6016 By Cmax pooled from all cohorts over full dose range.	Up to Day 14
CNTX-6016 Effect of Age and Sex in all Cohorts	Systemic exposure to CNTX-6016 By AUC pooled from all cohorts over full dose range.	Up to Day 14
CNTX-6016 Efficacy - PDN Cohort	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"	Up to Day 14
CNTX-6016 Efficacy - PDN Cohort	Efficacy measured by PainDETECT Questionnaire	Up to Day 14
CNTX-6016 Efficacy - PDN Cohort	Efficacy measured by Patient Global Impression of Change	Up to Day 14

Collaborators and Investigators

• Sponsor: Centrexion Therapeutics
• Investigators: Study Chair: Randall Stevens, MD, Centrexion Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2021
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: April 19, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (Actual): April 23, 2021

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Painful Diabetic Neuropathy
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pain; Diabetic Neuropathies
• Other Study ID Numbers: CNTX-6016o-HV/PDN-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No