A Placebo-Controlled, Two-Part Study, Oral Dose to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CNTX-6970 in Healthy Subjects

• Status: Completed
• Trial end date: 2018-09-26
• Target enrollment: 0
• Participant gender: All

Summary

A Phase 1, placebo-controlled, two part study with either single dose or multiple increasing oral dose to evaluate the safety, pharmacokinetics, and pharmacodynamics of CNTX-6970 in healthy subjects.

• 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 the Investigator's review

• Has a body mass index (BMI) between 18 and 35kg/m^2, inclusive

• For females, is not currently pregnant or breastfeeding 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:

• Has a history of cardiac disease, including congestive heart failure, angina, or any arrhythmia

• Has diabetes mellitus, acromegaly, clinically active thyroid disease, or other active endocrinopathy

• 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)

• Has used within 14 days prior to the first admission or has plans to use during the study any over-the-counter medicinal products, including herbal and dietary supplements (except for occasional use of acetaminophen or NSAIDs, such as ibuprofen or naproxen; calcium; or Vitamin D)

• Use of any of the following:

• Human growth hormone, octreotide, anti-diabetic medication, or thyroid suppressors or supplements

• Immunosuppressive drugs within 30 days of study start, or 5 half-lives of the drug (whichever is longer), or plans to use during the study