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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

CompletedPhase 1NCT03787004
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

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
Interventions
Sponsor
Centrexion Therapeutics
Start date
2017-08-14
Primary completion
2018-08-19
Sex
All
Age range
from 18 Years to 64 Years
Healthy volunteers
true
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03787004