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

NCT04857957 | Completed Phase 1 FDA Drug

• 1 other identifier: CNTX-6016o-HV/PDN-102
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Painful Diabetic Neuropathy

Keywords

Painful Diabetic Neuropathy

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• CNTX-6016 Effect of Age and Sex in all Cohorts

  Up to Day 14

• CNTX-6016 Effect of Age and Sex in all Cohorts

  Up to Day 14

• CNTX-6016 Efficacy - PDN Cohort

  Up to Day 14

Study Arms (4)

Cohort 1

EXPERIMENTAL

Dose 1

Drug: Oral dose CNTX-6016 or oral dose Placebo

Cohort 2

EXPERIMENTAL

Dose 2

Drug: Oral dose CNTX-6016 or oral dose Placebo

Cohort 3

EXPERIMENTAL

Dose 3

Drug: Oral dose CNTX-6016 or oral dose Placebo

PDN cohort

EXPERIMENTAL

Dose based on safety in healthy Cohorts 1-3

Drug: Oral dose CNTX-6016 or oral dose Placebo

Interventions

Oral dose CNTX-6016 or oral dose Placebo DRUG

CNTX-6016 or Placebo

Cohort 1; Cohort 2; Cohort 3; PDN cohort

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).
• 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
• 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.

Sponsors & Collaborators

• Centrexion Therapeutics: lead

Study Sites (1)

AltaSciences

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Randall Stevens, MD

  Centrexion Therapeutics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 23, 2021
• Study Start: April 14, 2021
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: July 28, 2025

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)