A Study to Evaluate the Safety and Pharmacokinetics of CNTX-6016 in Healthy Subjects

A Study to Evaluate the Safety and Pharmacokinetics of Single Doses of CNTX-6016 in Healthy Subjects

A Phase 1 double-blind, placebo-controlled, randomized single ascending dose incorporating an open-label, 2-period crossover, food effect cohort.

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.