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

• Status: Completed
• Trial end date: 2019-08-26
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Centrexion Therapeutics

Criteria

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.