Pain Clinical Trial
Official title:
A Study to Evaluate the Safety and Pharmacokinetics of Single Doses of CNTX-6016 in Healthy Subjects
Verified date | November 2019 |
Source | Centrexion Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A Phase 1 double-blind, placebo-controlled, randomized single ascending dose incorporating an open-label, 2-period crossover, food effect cohort.
Status | Completed |
Enrollment | 68 |
Est. completion date | August 26, 2019 |
Est. primary completion date | August 21, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Altasciences Clinical Research | Overland Park | Kansas |
Lead Sponsor | Collaborator |
---|---|
Centrexion Therapeutics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety of single doses of CNTX-6016 - TEAEs | Information regarding treatment emergent adverse events was collected during each dose cohort. | Up to 80 days | |
Primary | Dose Proportionality of a single doses of CNTX-6016 in healthy subjects | Dose Proportionality of a single doses of CNTX-6016 in healthy subjects. | 40 days | |
Primary | CNTX-6016 Pharmacokinetics - Cmax | Systemic exposure to CNTX-6016 measured by Cmax. | Up to 40 days | |
Primary | CNTX-6016 Pharmacokinetics - Tmax | Systemic exposure to CNTX-6016 measured by Tmax. | Up to 40 days | |
Primary | CNTX-6016 Pharmacokinetics - t1/2 | Systemic exposure to CNTX-6016 measured by t1/2. | Up to 40 days | |
Primary | CNTX-6016 Pharmacokinetics - AUC 0-t | Systemic exposure to CNTX-6016 measured by AUC 0-t. | Up to 40 days | |
Primary | CNTX-6016 Pharmacokinetics - AUC 0-inf | Systemic exposure to CNTX-6016 measured by AUC 0-inf. | Up to 40 days | |
Primary | CNTX-6016 Pharmacokinetics - AUC 0-t/inf | Systemic exposure to CNTX-6016 measured by AUC 0-t/inf. | Up to 40 days | |
Primary | CNTX-6016 Pharmacokinetics - CL/F | Systemic exposure to CNTX-6016 measured by CL/F. | Up to 40 days | |
Primary | CNTX-6016 Pharmacokinetics - Vz/F | Systemic exposure to CNTX-6016 measured by Vz/F. | Up to 40 days | |
Primary | Effect of Gender on CNTX-6016 Pharmacokinetics - Cmax | Effect of Gender on the systemic exposure to CNTX-6016 measured by Cmax. | Up to 80 days | |
Primary | Effect of Gender on CNTX-6016 Pharmacokinetics - Tmax | Effect of Gender on the systemic exposure to CNTX-6016 measured by tmax. | Up to 80 days | |
Primary | Effect of Gender on CNTX-6016 Pharmacokinetics - t1/2 | Effect of Gender on the systemic exposure to CNTX-6016 measured by t1/2 | Up to 80 days | |
Primary | Effect of Gender on CNTX-6016 Pharmacokinetics - AUC | Effect of Gender on the systemic exposure to CNTX-6016 measured by AUC. | Up to 80 days | |
Primary | Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - Cmax | Systemic exposure to CNTX-6016 in fasted or fed state as measured by Cmax | Up to 40 days | |
Primary | Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - Tmax | Systemic exposure to CNTX-6016 in fasted or fed state as measured by Tmax | Up to 40 days | |
Primary | Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - t1/2 | Systemic exposure to CNTX-6016 in fasted or fed state as measured by t1/2 | Up to 40 days | |
Primary | Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - AUC | Systemic exposure to CNTX-6016 in fasted or fed state as measured by AUC | Up to 40 days | |
Primary | Urinary Excretion | Urine was collected over a 3-day period (0-72 hrs) in Cohort 8 and analyzed for concentrations of CNTX-6016 in subjects in both the fasted and fed states using Liquid Chromatography Mass Spectrometry. | Up to 6 days | |
Secondary | Plasma and Urine Metabolite Mining | Urine was collected over a 3-day period (0-72hrs) in Cohort 9 (1000mg) and analyzed for concentrations of parent and metabolites of CNTX-6016 using Liquid Chromatography Mass Spectrometry. | 5 days |
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