Status:
COMPLETED
A Placebo-Controlled, Two-Part Study, Oral Dose to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CNTX-6970 in Healthy Subjects
Lead Sponsor:
Centrexion Therapeutics
Conditions:
Chronic Pain
Nociceptive Pain
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
August 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2018
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT03787004
Start Date
August 14 2017
End Date
September 26 2018
Last Update
December 26 2018
Active Locations (1)
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1
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, United States, 45227