A Study to Evaluate the Safety and Pharmacokinetics of CNTX-6016 in Healthy Subjects
- Registration Number
- NCT04154501
- Lead Sponsor
- Centrexion Therapeutics
- Brief Summary
A Phase 1 double-blind, placebo-controlled, randomized single ascending dose incorporating an open-label, 2-period crossover, food effect cohort.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Cohort 4 Drug CNTX-6016 300 mg Oral Capsule Cohort 1 Drug CNTX-6016 25 mg Oral Capsule Cohort 2 Drug CNTX-6016 50 mg Oral Capsule Cohort 6 Drug CNTX-6016 600 mg Oral Capsule Cohort 7 Drug CNTX-6016 800 mg Oral Capsule Cohort 9 Drug CNTX-6016 1000 mg Oral Capsule Cohort 5 Drug CNTX-6016 450 mg Oral Capsule Cohort 3 Drug CNTX-6016 100 mg Oral Capsule Cohort 8 Fasted CNTX-6016 Participant will take 300 mg Oral Capsule in a fasting state, and then fed state. Cohort 8 Fed CNTX-6016 Participant will take 300 mg Oral Capsule in a fed state, and then fasting state.
- Primary Outcome Measures
Name Time Method Safety of single doses of CNTX-6016 - TEAEs Up to 80 days Information regarding treatment emergent adverse events was collected during each dose cohort.
Dose Proportionality of a single doses of CNTX-6016 in healthy subjects 40 days Dose Proportionality of a single doses of CNTX-6016 in healthy subjects.
CNTX-6016 Pharmacokinetics - Tmax Up to 40 days Systemic exposure to CNTX-6016 measured by Tmax.
CNTX-6016 Pharmacokinetics - t1/2 Up to 40 days Systemic exposure to CNTX-6016 measured by t1/2.
CNTX-6016 Pharmacokinetics - AUC 0-inf Up to 40 days Systemic exposure to CNTX-6016 measured by AUC 0-inf.
CNTX-6016 Pharmacokinetics - AUC 0-t/inf Up to 40 days Systemic exposure to CNTX-6016 measured by AUC 0-t/inf.
CNTX-6016 Pharmacokinetics - CL/F Up to 40 days Systemic exposure to CNTX-6016 measured by CL/F.
Effect of Gender on CNTX-6016 Pharmacokinetics - Tmax Up to 80 days Effect of Gender on the systemic exposure to CNTX-6016 measured by tmax.
Effect of Gender on CNTX-6016 Pharmacokinetics - t1/2 Up to 80 days Effect of Gender on the systemic exposure to CNTX-6016 measured by t1/2
Effect of Gender on CNTX-6016 Pharmacokinetics - AUC Up to 80 days Effect of Gender on the systemic exposure to CNTX-6016 measured by AUC.
Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - Cmax Up to 40 days Systemic exposure to CNTX-6016 in fasted or fed state as measured by Cmax
Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - Tmax Up to 40 days Systemic exposure to CNTX-6016 in fasted or fed state as measured by Tmax
Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - t1/2 Up to 40 days Systemic exposure to CNTX-6016 in fasted or fed state as measured by t1/2
Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - AUC Up to 40 days Systemic exposure to CNTX-6016 in fasted or fed state as measured by AUC
Urinary Excretion Up to 6 days 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.
CNTX-6016 Pharmacokinetics - Cmax Up to 40 days Systemic exposure to CNTX-6016 measured by Cmax.
CNTX-6016 Pharmacokinetics - AUC 0-t Up to 40 days Systemic exposure to CNTX-6016 measured by AUC 0-t.
CNTX-6016 Pharmacokinetics - Vz/F Up to 40 days Systemic exposure to CNTX-6016 measured by Vz/F.
Effect of Gender on CNTX-6016 Pharmacokinetics - Cmax Up to 80 days Effect of Gender on the systemic exposure to CNTX-6016 measured by Cmax.
- Secondary Outcome Measures
Name Time Method Plasma and Urine Metabolite Mining 5 days 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.
Trial Locations
- Locations (1)
Altasciences Clinical Research
🇺🇸Overland Park, Kansas, United States