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A Placebo-Controlled, Two-Part Study, Oral Dose to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CNTX-6970 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT03787004
Recruitment Status : Completed
First Posted : December 25, 2018
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
Centrexion Therapeutics

Brief Summary:
A Phase 1, placebo-controlled, two part study with either single dose or multiple increasing oral dose to evaluate the safety, pharmacokinetics, and pharmacodynamics of CNTX-6970 in healthy subjects.

Condition or disease Intervention/treatment Phase
Chronic Pain Nociceptive Pain Drug: CNTX-6970 Other: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Part 1: Open Label Part 2: Double-Blind
Primary Purpose: Treatment
Official Title: A Placebo-Controlled, Two-Part Study With Single Dose and Multiple Ascending Oral Dose to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CNTX-6970 in Healthy Subjects
Actual Study Start Date : August 14, 2017
Actual Primary Completion Date : August 19, 2018
Actual Study Completion Date : September 26, 2018

Arm Intervention/treatment
Experimental: Part 1 Cohort 1 (Single Dose)
Single 100 mg oral dose of CNTX-6970 (film-coated tablet or enteric-coated tablet)
Drug: CNTX-6970
Oral dose CNTX-6970

Experimental: Part 1 Cohort 2 (Single Dose)
Single 100 mg oral dose of CNTX-6970 film-coated tablet
Drug: CNTX-6970
Oral dose CNTX-6970

Experimental: Part 2 (Multiple Ascending Dose)
100 mg, 300 mg, and 600 mg CNTX-6970 oral tablet
Drug: CNTX-6970
Oral dose CNTX-6970

Placebo Comparator: Part 2 Placebo
Placebo oral tablet
Other: Placebo
Oral dose placebo




Primary Outcome Measures :
  1. CNTX-6970 Pharmacokinetics - fasted state or high-fat standardized meal [ Time Frame: Up to Day 3 ]
    Food effects on pharmacokinetics of CTNX-6790 for Part 1 participants

  2. CNTX-6970 Pharmacokinetics - AUC0-t [ Time Frame: Up to Day 13 ]
    Systemic exposure to CNTX-6970 measured by AUC0-t

  3. CNTX-6970 Pharmacokinetics - AUC0-inf [ Time Frame: Up to Day 13 ]
    Systemic exposure to CNTX-6970 measured by AUC0-inf

  4. CNTX-6970 Pharmacokinetics - Cmax [ Time Frame: Up to Day 13 ]
    Systemic exposure to CNTX-6970 measured by Cmax

  5. CNTX-6970 Pharmacokinetics - tmax [ Time Frame: Up to Day 13 ]
    Systemic exposure to CNTX-6970 measured by tmax

  6. CNTX-6970 Pharmacokinetics - t1/2 [ Time Frame: Up to Day 13 ]
    Systemic exposure to CNTX-6970 measured by t1/2


Secondary Outcome Measures :
  1. Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability) [ Time Frame: Up to Day 13 ]
    Number of participants with TEAEs, which includes laboratory test variables

  2. CNTX-6970 Pharmacodynamics - Emax [ Time Frame: Up to Day 13 ]
    Pharmacodynamic effect on MCP-1 and RANTES measured by Emax

  3. CNTX-6970 Pharmacodynamics - PD tmax [ Time Frame: Up to Day 13 ]
    Time to maximum pharmacodynamic effect on MCP-1 and RANTES measured by tmax



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  • Is in good general health as determined by the Investigator's review
  • Has a body mass index (BMI) between 18 and 35kg/m^2, inclusive
  • For females, is not currently pregnant or breastfeeding 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:

  • Has a history of cardiac disease, including congestive heart failure, angina, or any arrhythmia
  • Has diabetes mellitus, acromegaly, clinically active thyroid disease, or other active endocrinopathy
  • Has any history or currently active type of cancer except excised or cured basal cell carcinoma
  • Has a gastrointestinal disorder that could interfere with the absorption of orally administered drugs
  • Has asthma or other severe respiratory disease (e.g., chronic obstructive pulmonary disease) requiring daily prescription medicine
  • Currently has kidney, neurologic, metabolic, or liver disease, or other organ system disease
  • Has a history, current evidence, or is being treated for depression, suicidal ideation, suicide attempt, or any other current psychiatric condition requiring active treatment
  • 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
  • Has positive screening test for hepatitis B virus (HBV) or hepatitis C virus (HCV);
  • Is pregnant, lactating, or planning a pregnancy during the study
  • Has used any prescribed medication within 30 days prior to the first admission or has plans to use any prescribed medication during the study (with the exception of hormonal contraceptives)
  • Has used within 14 days prior to the first admission or has plans to use during the study any over-the-counter medicinal products, including herbal and dietary supplements (except for occasional use of acetaminophen or NSAIDs, such as ibuprofen or naproxen; calcium; or Vitamin D)
  • Use of any of the following:

    • Human growth hormone, octreotide, anti-diabetic medication, or thyroid suppressors or supplements
    • Immunosuppressive drugs within 30 days of study start, or 5 half-lives of the drug (whichever is longer), or plans to use during the study

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): NCT03787004


Locations
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United States, Ohio
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, United States, 45227
Sponsors and Collaborators
Centrexion Therapeutics
Investigators
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Study Chair: Randall M. Stevens, MD Centrexion Therapeutics

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Responsible Party: Centrexion Therapeutics
ClinicalTrials.gov Identifier: NCT03787004     History of Changes
Other Study ID Numbers: CNTX-6970-HV-102
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018

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

Keywords provided by Centrexion Therapeutics:
Chronic Pain
Nociceptive Pain
Mixed Pain

Additional relevant MeSH terms:
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Chronic Pain
Nociceptive Pain
Pain
Neurologic Manifestations
Signs and Symptoms