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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Nociceptive Pain
• Intervention / Treatment: Drug: CNTX-6970; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45227
      • Medpace Clinical Pharmacology Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1 Cohort 1 (Single Dose); Single 100 mg oral dose of CNTX-6970 (film-coated tablet or enteric-coated tablet)	Drug: CNTX-6970; Oral dose CNTX-6970
Experimental: Part 1 Cohort 2 (Single Dose); Single 100 mg oral dose of CNTX-6970 film-coated tablet	Drug: CNTX-6970; Oral dose CNTX-6970
Experimental: Part 2 (Multiple Ascending Dose); 100 mg, 300 mg, and 600 mg CNTX-6970 oral tablet	Drug: CNTX-6970; Oral dose CNTX-6970
Placebo Comparator: Part 2 Placebo; Placebo oral tablet	Other: Placebo; Oral dose placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CNTX-6970 Pharmacokinetics - fasted state or high-fat standardized meal	Food effects on pharmacokinetics of CTNX-6790 for Part 1 participants	Up to Day 3
CNTX-6970 Pharmacokinetics - AUC0-t	Systemic exposure to CNTX-6970 measured by AUC0-t	Up to Day 13
CNTX-6970 Pharmacokinetics - AUC0-inf	Systemic exposure to CNTX-6970 measured by AUC0-inf	Up to Day 13
CNTX-6970 Pharmacokinetics - Cmax	Systemic exposure to CNTX-6970 measured by Cmax	Up to Day 13
CNTX-6970 Pharmacokinetics - tmax	Systemic exposure to CNTX-6970 measured by tmax	Up to Day 13
CNTX-6970 Pharmacokinetics - t1/2	Systemic exposure to CNTX-6970 measured by t1/2	Up to Day 13

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability)	Number of participants with TEAEs, which includes laboratory test variables	Up to Day 13
CNTX-6970 Pharmacodynamics - Emax	Pharmacodynamic effect on MCP-1 and RANTES measured by Emax	Up to Day 13
CNTX-6970 Pharmacodynamics - PD tmax	Time to maximum pharmacodynamic effect on MCP-1 and RANTES measured by tmax	Up to Day 13

Collaborators and Investigators

• Sponsor: Centrexion Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2017
• Primary Completion (Actual): August 19, 2018
• Study Completion (Actual): September 26, 2018

Study Registration Dates

• First Submitted: December 21, 2018
• First Submitted That Met QC Criteria: December 21, 2018
• First Posted (Actual): December 26, 2018

Study Record Updates

• Last Update Posted (Actual): December 26, 2018
• Last Update Submitted That Met QC Criteria: December 21, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Chronic Pain; Nociceptive Pain; Mixed Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Nociceptive Pain
• Other Study ID Numbers: CNTX-6970-HV-102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No