Clinical trial NCT03787004: A Placebo-Controlled, Two-Part Study, Oral Dose to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CNTX-6970 in Healthy Subjects
Official title: A Placebo-Controlled, Two-Part Study With Single Dose and Multiple Ascending Oral Dose to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CNTX-6970 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Pain
Nociceptive Pain
Keywords: Chronic Pain
Nociceptive Pain
Mixed Pain
Lead sponsor: Centrexion Therapeutics
Sponsor class: INDUSTRY
First posted: 2018-12-26
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: CNTX-6970 Pharmacokinetics - fasted state or high-fat standardized meal
timeFrame: Up to Day 3
measure: CNTX-6970 Pharmacokinetics - AUC0-t
timeFrame: Up to Day 13
measure: CNTX-6970 Pharmacokinetics - AUC0-inf
timeFrame: Up to Day 13
measure: CNTX-6970 Pharmacokinetics - Cmax
timeFrame: Up to Day 13
measure: CNTX-6970 Pharmacokinetics - tmax
timeFrame: Up to Day 13
measure: CNTX-6970 Pharmacokinetics - t1/2
timeFrame: Up to Day 13
Secondary outcomes:
measure: Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability)
timeFrame: Up to Day 13
measure: CNTX-6970 Pharmacodynamics - Emax
timeFrame: Up to Day 13
measure: CNTX-6970 Pharmacodynamics - PD tmax
timeFrame: Up to Day 13
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Medpace Clinical Pharmacology Unit
state: Ohio
Study officials:
affiliation: Centrexion Therapeutics
name: Randall M. Stevens, MD
role: STUDY_CHAIR
References: