Expired Study
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Cincinnati, Ohio 45227


Purpose:

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.


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


NCT ID:

NCT03787004


Primary Contact:

Study Chair
Randall M. Stevens, MD
Centrexion Therapeutics


Backup Contact:

N/A


Location Contact:

Cincinnati, Ohio 45227
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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