A Study to Evaluate the Safety and Pharmacokinetics of CNTX-6016 in Healthy Subjects
CompletedPhase 1NCT04154501
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 double-blind, placebo-controlled, randomized single ascending dose incorporating an open-label, 2-period crossover, food effect cohort.
Study details
- Official title
- A Study to Evaluate the Safety and Pharmacokinetics of Single Doses of CNTX-6016 in Healthy Subjects
- Conditions
- Interventions
- Drug: CNTX-6016
- Other: Other: Placebo
- Sponsor
- Centrexion Therapeutics
- Start date
- 2018-12-04
- Primary completion
- 2019-08-21
- Sex
- All
- Age range
- from 18 Years to 55 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 Investigator's review. * Has a body mass index (BMI) between 18 and 35 kg/m2. * Non- or ex-smoker (\> 1 year) and has not used any nicotine containing products within 12 months prior to screening. * For females, is not currently pregnant 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: * History of or active cardiac disease, including congestive heart failure, angina, or any arrhythmia. * 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). * Positive urine screen for alcohol, cotinine, THC and/or drugs of abuse. * Ingestion of food or beverages containing grapefruit and/or grapefruit juice and/or pomelos during the 7 days prior to dosing and/or during the study period.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04154501