search
Back to results

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

Primary Purpose

Painful Diabetic Neuropathy

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Oral dose CNTX-6016 or oral dose Placebo
Sponsored by
Centrexion Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Painful Diabetic Neuropathy focused on measuring Painful Diabetic Neuropathy

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • AltaSciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

PDN cohort

Arm Description

300 mg oral dose TID

600 mg oral dose TID

800 mg oral dose TID

Dose based on safety in healthy Cohorts 1-3

Outcomes

Primary Outcome Measures

Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability) with CNTX-6016
Number of participants with TEAEs, which includes laboratory test variables
CNTX-6016 Pharmacokinetics - Cmax
Systemic exposure to CNTX-6016 measured by Cmax
CNTX-6016 Pharmacokinetics - AUC0-t
Systemic exposure to CNTX-6016 measured by AUC0-t
CNTX-6016 Pharmacokinetics - t1/2
Systemic exposure to CNTX-6016 measured by t1/2
CNTX-6016 Pharmacokinetics - tmax
Systemic exposure to CNTX-6016 measured by tmax

Secondary Outcome Measures

Full Information

First Posted
April 19, 2021
Last Updated
April 22, 2021
Sponsor
Centrexion Therapeutics
search

1. Study Identification

Unique Protocol Identification Number
NCT04857957
Brief Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 14, 2021 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
March 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centrexion Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
A Phase 1b/2a 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Painful Diabetic Neuropathy
Keywords
Painful Diabetic Neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
300 mg oral dose TID
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
600 mg oral dose TID
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
800 mg oral dose TID
Arm Title
PDN cohort
Arm Type
Experimental
Arm Description
Dose based on safety in healthy Cohorts 1-3
Intervention Type
Drug
Intervention Name(s)
Oral dose CNTX-6016 or oral dose Placebo
Intervention Description
CNTX-6016 or Placebo
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability) with CNTX-6016
Description
Number of participants with TEAEs, which includes laboratory test variables
Time Frame
Up to 45 days
Title
CNTX-6016 Pharmacokinetics - Cmax
Description
Systemic exposure to CNTX-6016 measured by Cmax
Time Frame
Up to Day 6
Title
CNTX-6016 Pharmacokinetics - AUC0-t
Description
Systemic exposure to CNTX-6016 measured by AUC0-t
Time Frame
Up to Day 6
Title
CNTX-6016 Pharmacokinetics - t1/2
Description
Systemic exposure to CNTX-6016 measured by t1/2
Time Frame
Up to Day 6
Title
CNTX-6016 Pharmacokinetics - tmax
Description
Systemic exposure to CNTX-6016 measured by tmax
Time Frame
Up to Day 6
Other Pre-specified Outcome Measures:
Title
CNTX-6016 Effect of Age and Sex in all Cohorts
Description
Systemic exposure to CNTX-6016 By Cmax pooled from all cohorts over full dose range.
Time Frame
Up to Day 14
Title
CNTX-6016 Effect of Age and Sex in all Cohorts
Description
Systemic exposure to CNTX-6016 By AUC pooled from all cohorts over full dose range.
Time Frame
Up to Day 14
Title
CNTX-6016 Efficacy - PDN Cohort
Description
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"
Time Frame
Up to Day 14
Title
CNTX-6016 Efficacy - PDN Cohort
Description
Efficacy measured by PainDETECT Questionnaire
Time Frame
Up to Day 14
Title
CNTX-6016 Efficacy - PDN Cohort
Description
Efficacy measured by Patient Global Impression of Change
Time Frame
Up to Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study manager
Phone
617-837-6911
Email
info@centrexion.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Tiseo, PhD
Organizational Affiliation
Centrexion Therapeutics
Official's Role
Study Chair
Facility Information:
Facility Name
AltaSciences
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Kankam, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs