A Placebo-Controlled, Two-Part Study, Oral Dose to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CNTX-6970 in Healthy Subjects
- Registration Number
- NCT03787004
- Lead Sponsor
- Centrexion Therapeutics
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
- 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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1 Cohort 2 (Single Dose) CNTX-6970 Single 100 mg oral dose of CNTX-6970 film-coated tablet Part 2 (Multiple Ascending Dose) CNTX-6970 100 mg, 300 mg, and 600 mg CNTX-6970 oral tablet Part 2 Placebo Placebo Placebo oral tablet Part 1 Cohort 1 (Single Dose) CNTX-6970 Single 100 mg oral dose of CNTX-6970 (film-coated tablet or enteric-coated tablet)
- Primary Outcome Measures
Name Time Method CNTX-6970 Pharmacokinetics - AUC0-inf Up to Day 13 Systemic exposure to CNTX-6970 measured by AUC0-inf
CNTX-6970 Pharmacokinetics - fasted state or high-fat standardized meal Up to Day 3 Food effects on pharmacokinetics of CTNX-6790 for Part 1 participants
CNTX-6970 Pharmacokinetics - AUC0-t Up to Day 13 Systemic exposure to CNTX-6970 measured by AUC0-t
CNTX-6970 Pharmacokinetics - Cmax Up to Day 13 Systemic exposure to CNTX-6970 measured by Cmax
CNTX-6970 Pharmacokinetics - tmax Up to Day 13 Systemic exposure to CNTX-6970 measured by tmax
CNTX-6970 Pharmacokinetics - t1/2 Up to Day 13 Systemic exposure to CNTX-6970 measured by t1/2
- Secondary Outcome Measures
Name Time Method CNTX-6970 Pharmacodynamics - PD tmax Up to Day 13 Time to maximum pharmacodynamic effect on MCP-1 and RANTES measured by tmax
Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability) Up to Day 13 Number of participants with TEAEs, which includes laboratory test variables
CNTX-6970 Pharmacodynamics - Emax Up to Day 13 Pharmacodynamic effect on MCP-1 and RANTES measured by Emax
Trial Locations
- Locations (1)
Medpace Clinical Pharmacology Unit
🇺🇸Cincinnati, Ohio, United States