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Completed

NCT Number: NCT03787004

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

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Medpace Clinical Pharmacology Unit

Cincinnati, Ohio, 45227, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CNTX-6970

Drug

Oral dose CNTX-6970

Placebo

Other

Oral dose placebo

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centrexion Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 26, 2018
Registry last updated
Dec 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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