Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04857957
Recruitment Status : Recruiting
First Posted : April 23, 2021
Last Update Posted : April 23, 2021
Sponsor:
Information provided by (Responsible Party):
Centrexion Therapeutics

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Painful Diabetic Neuropathy Drug: Oral dose CNTX-6016 or oral dose Placebo Phase 1 Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 14, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures:
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04857957


Contacts
Layout table for location contacts
Contact: Study manager 617-837-6911 info@centrexion.com

Locations
Layout table for location information
United States, Kansas
AltaSciences Recruiting
Overland Park, Kansas, United States, 66212
Contact: Martin Kankam, MD         
Sponsors and Collaborators
Centrexion Therapeutics
Investigators
Layout table for investigator information
Study Chair: Paul Tiseo, PhD Centrexion Therapeutics
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Centrexion Therapeutics
ClinicalTrials.gov Identifier: NCT04857957    
Other Study ID Numbers: CNTX-6016o-HV/PDN-102
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: April 23, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centrexion Therapeutics:
Painful Diabetic Neuropathy
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetic Neuropathies
Pain
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
 Neurologic Manifestations
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases