A Placebo-Controlled, Two-Part Study, Oral Dose to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CNTX-6970 in Healthy Subjects
Primary Purpose
Chronic Pain, Nociceptive Pain
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CNTX-6970
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Chronic Pain, Nociceptive Pain, Mixed Pain
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
Sites / Locations
- Medpace Clinical Pharmacology Unit
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Part 1 Cohort 1 (Single Dose)
Part 1 Cohort 2 (Single Dose)
Part 2 (Multiple Ascending Dose)
Part 2 Placebo
Arm Description
Single 100 mg oral dose of CNTX-6970 (film-coated tablet or enteric-coated tablet)
Single 100 mg oral dose of CNTX-6970 film-coated tablet
100 mg, 300 mg, and 600 mg CNTX-6970 oral tablet
Placebo oral tablet
Outcomes
Primary Outcome Measures
CNTX-6970 Pharmacokinetics - fasted state or high-fat standardized meal
Food effects on pharmacokinetics of CTNX-6790 for Part 1 participants
CNTX-6970 Pharmacokinetics - AUC0-t
Systemic exposure to CNTX-6970 measured by AUC0-t
CNTX-6970 Pharmacokinetics - AUC0-inf
Systemic exposure to CNTX-6970 measured by AUC0-inf
CNTX-6970 Pharmacokinetics - Cmax
Systemic exposure to CNTX-6970 measured by Cmax
CNTX-6970 Pharmacokinetics - tmax
Systemic exposure to CNTX-6970 measured by tmax
CNTX-6970 Pharmacokinetics - t1/2
Systemic exposure to CNTX-6970 measured by t1/2
Secondary Outcome Measures
Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability)
Number of participants with TEAEs, which includes laboratory test variables
CNTX-6970 Pharmacodynamics - Emax
Pharmacodynamic effect on MCP-1 and RANTES measured by Emax
CNTX-6970 Pharmacodynamics - PD tmax
Time to maximum pharmacodynamic effect on MCP-1 and RANTES measured by tmax
Full Information
NCT ID
NCT03787004
First Posted
December 21, 2018
Last Updated
December 21, 2018
Sponsor
Centrexion Therapeutics
1. Study Identification
Unique Protocol Identification Number
NCT03787004
Brief Title
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
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
August 14, 2017 (Actual)
Primary Completion Date
August 19, 2018 (Actual)
Study Completion Date
September 26, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centrexion Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Nociceptive Pain
Keywords
Chronic Pain, Nociceptive Pain, Mixed Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Part 1: Open Label Part 2: Double-Blind
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part 1 Cohort 1 (Single Dose)
Arm Type
Experimental
Arm Description
Single 100 mg oral dose of CNTX-6970 (film-coated tablet or enteric-coated tablet)
Arm Title
Part 1 Cohort 2 (Single Dose)
Arm Type
Experimental
Arm Description
Single 100 mg oral dose of CNTX-6970 film-coated tablet
Arm Title
Part 2 (Multiple Ascending Dose)
Arm Type
Experimental
Arm Description
100 mg, 300 mg, and 600 mg CNTX-6970 oral tablet
Arm Title
Part 2 Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo oral tablet
Intervention Type
Drug
Intervention Name(s)
CNTX-6970
Intervention Description
Oral dose CNTX-6970
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Oral dose placebo
Primary Outcome Measure Information:
Title
CNTX-6970 Pharmacokinetics - fasted state or high-fat standardized meal
Description
Food effects on pharmacokinetics of CTNX-6790 for Part 1 participants
Time Frame
Up to Day 3
Title
CNTX-6970 Pharmacokinetics - AUC0-t
Description
Systemic exposure to CNTX-6970 measured by AUC0-t
Time Frame
Up to Day 13
Title
CNTX-6970 Pharmacokinetics - AUC0-inf
Description
Systemic exposure to CNTX-6970 measured by AUC0-inf
Time Frame
Up to Day 13
Title
CNTX-6970 Pharmacokinetics - Cmax
Description
Systemic exposure to CNTX-6970 measured by Cmax
Time Frame
Up to Day 13
Title
CNTX-6970 Pharmacokinetics - tmax
Description
Systemic exposure to CNTX-6970 measured by tmax
Time Frame
Up to Day 13
Title
CNTX-6970 Pharmacokinetics - t1/2
Description
Systemic exposure to CNTX-6970 measured by t1/2
Time Frame
Up to Day 13
Secondary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability)
Description
Number of participants with TEAEs, which includes laboratory test variables
Time Frame
Up to Day 13
Title
CNTX-6970 Pharmacodynamics - Emax
Description
Pharmacodynamic effect on MCP-1 and RANTES measured by Emax
Time Frame
Up to Day 13
Title
CNTX-6970 Pharmacodynamics - PD tmax
Description
Time to maximum pharmacodynamic effect on MCP-1 and RANTES measured by tmax
Time Frame
Up to Day 13
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randall M. Stevens, MD
Organizational Affiliation
Centrexion Therapeutics
Official's Role
Study Chair
Facility Information:
Facility Name
Medpace Clinical Pharmacology Unit
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Placebo-Controlled, Two-Part Study, Oral Dose to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CNTX-6970 in Healthy Subjects
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