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A Study to Evaluate the Safety and Pharmacokinetics of CNTX-6016 in Healthy Subjects

Primary Purpose

Chronic Pain, Nociceptive Pain, Pain

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CNTX-6016
Other: Placebo
Sponsored by
Centrexion Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Chronic Pain, Nociceptive Pain, Mixed Pain, Cannabinoid, Cannabinoid-2 Receptor Agonist

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Key Inclusion Criteria:

  • Is in good general health as determined by Investigator's review.
  • Has a body mass index (BMI) between 18 and 35 kg/m2.
  • Non- or ex-smoker (> 1 year) and has not used any nicotine containing products within 12 months prior to screening.
  • For females, is not currently pregnant 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:

  • History of or active cardiac disease, including congestive heart failure, angina, or any arrhythmia.
  • 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).
  • Positive urine screen for alcohol, cotinine, THC and/or drugs of abuse.
  • Ingestion of food or beverages containing grapefruit and/or grapefruit juice and/or pomelos during the 7 days prior to dosing and/or during the study period.

Sites / Locations

  • Altasciences Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm 18

Arm Type

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Cohort 1 Placebo

Cohort 1 Drug

Cohort 2 Placebo

Cohort 2 Drug

Cohort 3 Placebo

Cohort 3 Drug

Cohort 4 Placebo

Cohort 4 Drug

Cohort 5 Placebo

Cohort 5 Drug

Cohort 6 Placebo

Cohort 6 Drug

Cohort 7 Placebo

Cohort 7 Drug

Cohort 9 Placebo

Cohort 9 Drug

Cohort 8 Fasted

Cohort 8 Fed

Arm Description

Oral Placebo Capsule

25 mg Oral Capsule

Oral Placebo Capsule

50 mg Oral Capsule

Oral Placebo Capsule

100 mg Oral Capsule

Oral Placebo Capsule

300 mg Oral Capsule

Oral Placebo Capsule

450 mg Oral Capsule

Oral Placebo Capsule

600 mg Oral Capsule

Oral Placebo Capsule

800 mg Oral Capsule

Oral Placebo Capsule

1000 mg Oral Capsule

Participant will take 300 mg Oral Capsule in a fasting state, and then fed state.

Participant will take 300 mg Oral Capsule in a fed state, and then fasting state.

Outcomes

Primary Outcome Measures

Safety of single doses of CNTX-6016 - TEAEs
Information regarding treatment emergent adverse events was collected during each dose cohort.
Dose Proportionality of a single doses of CNTX-6016 in healthy subjects
Dose Proportionality of a single doses of CNTX-6016 in healthy subjects.
CNTX-6016 Pharmacokinetics - Cmax
Systemic exposure to CNTX-6016 measured by Cmax.
CNTX-6016 Pharmacokinetics - Tmax
Systemic exposure to CNTX-6016 measured by Tmax.
CNTX-6016 Pharmacokinetics - t1/2
Systemic exposure to CNTX-6016 measured by t1/2.
CNTX-6016 Pharmacokinetics - AUC 0-t
Systemic exposure to CNTX-6016 measured by AUC 0-t.
CNTX-6016 Pharmacokinetics - AUC 0-inf
Systemic exposure to CNTX-6016 measured by AUC 0-inf.
CNTX-6016 Pharmacokinetics - AUC 0-t/inf
Systemic exposure to CNTX-6016 measured by AUC 0-t/inf.
CNTX-6016 Pharmacokinetics - CL/F
Systemic exposure to CNTX-6016 measured by CL/F.
CNTX-6016 Pharmacokinetics - Vz/F
Systemic exposure to CNTX-6016 measured by Vz/F.
Effect of Gender on CNTX-6016 Pharmacokinetics - Cmax
Effect of Gender on the systemic exposure to CNTX-6016 measured by Cmax.
Effect of Gender on CNTX-6016 Pharmacokinetics - Tmax
Effect of Gender on the systemic exposure to CNTX-6016 measured by tmax.
Effect of Gender on CNTX-6016 Pharmacokinetics - t1/2
Effect of Gender on the systemic exposure to CNTX-6016 measured by t1/2
Effect of Gender on CNTX-6016 Pharmacokinetics - AUC
Effect of Gender on the systemic exposure to CNTX-6016 measured by AUC.
Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - Cmax
Systemic exposure to CNTX-6016 in fasted or fed state as measured by Cmax
Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - Tmax
Systemic exposure to CNTX-6016 in fasted or fed state as measured by Tmax
Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - t1/2
Systemic exposure to CNTX-6016 in fasted or fed state as measured by t1/2
Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - AUC
Systemic exposure to CNTX-6016 in fasted or fed state as measured by AUC
Urinary Excretion
Urine was collected over a 3-day period (0-72 hrs) in Cohort 8 and analyzed for concentrations of CNTX-6016 in subjects in both the fasted and fed states using Liquid Chromatography Mass Spectrometry.

Secondary Outcome Measures

Plasma and Urine Metabolite Mining
Urine was collected over a 3-day period (0-72hrs) in Cohort 9 (1000mg) and analyzed for concentrations of parent and metabolites of CNTX-6016 using Liquid Chromatography Mass Spectrometry.

Full Information

First Posted
October 7, 2019
Last Updated
November 4, 2019
Sponsor
Centrexion Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT04154501
Brief Title
A Study to Evaluate the Safety and Pharmacokinetics of CNTX-6016 in Healthy Subjects
Official Title
A Study to Evaluate the Safety and Pharmacokinetics of Single Doses of CNTX-6016 in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
December 4, 2018 (Actual)
Primary Completion Date
August 21, 2019 (Actual)
Study Completion Date
August 26, 2019 (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
Yes

5. Study Description

Brief Summary
A Phase 1 double-blind, placebo-controlled, randomized single ascending dose incorporating an open-label, 2-period crossover, food effect cohort.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Nociceptive Pain, Pain
Keywords
Chronic Pain, Nociceptive Pain, Mixed Pain, Cannabinoid, Cannabinoid-2 Receptor Agonist

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1 Placebo
Arm Type
Placebo Comparator
Arm Description
Oral Placebo Capsule
Arm Title
Cohort 1 Drug
Arm Type
Experimental
Arm Description
25 mg Oral Capsule
Arm Title
Cohort 2 Placebo
Arm Type
Placebo Comparator
Arm Description
Oral Placebo Capsule
Arm Title
Cohort 2 Drug
Arm Type
Experimental
Arm Description
50 mg Oral Capsule
Arm Title
Cohort 3 Placebo
Arm Type
Placebo Comparator
Arm Description
Oral Placebo Capsule
Arm Title
Cohort 3 Drug
Arm Type
Experimental
Arm Description
100 mg Oral Capsule
Arm Title
Cohort 4 Placebo
Arm Type
Placebo Comparator
Arm Description
Oral Placebo Capsule
Arm Title
Cohort 4 Drug
Arm Type
Experimental
Arm Description
300 mg Oral Capsule
Arm Title
Cohort 5 Placebo
Arm Type
Placebo Comparator
Arm Description
Oral Placebo Capsule
Arm Title
Cohort 5 Drug
Arm Type
Experimental
Arm Description
450 mg Oral Capsule
Arm Title
Cohort 6 Placebo
Arm Type
Placebo Comparator
Arm Description
Oral Placebo Capsule
Arm Title
Cohort 6 Drug
Arm Type
Experimental
Arm Description
600 mg Oral Capsule
Arm Title
Cohort 7 Placebo
Arm Type
Placebo Comparator
Arm Description
Oral Placebo Capsule
Arm Title
Cohort 7 Drug
Arm Type
Experimental
Arm Description
800 mg Oral Capsule
Arm Title
Cohort 9 Placebo
Arm Type
Placebo Comparator
Arm Description
Oral Placebo Capsule
Arm Title
Cohort 9 Drug
Arm Type
Experimental
Arm Description
1000 mg Oral Capsule
Arm Title
Cohort 8 Fasted
Arm Type
Experimental
Arm Description
Participant will take 300 mg Oral Capsule in a fasting state, and then fed state.
Arm Title
Cohort 8 Fed
Arm Type
Experimental
Arm Description
Participant will take 300 mg Oral Capsule in a fed state, and then fasting state.
Intervention Type
Drug
Intervention Name(s)
CNTX-6016
Intervention Description
Oral Dose CNTX-6016
Intervention Type
Other
Intervention Name(s)
Other: Placebo
Intervention Description
Oral Dose Placebo
Primary Outcome Measure Information:
Title
Safety of single doses of CNTX-6016 - TEAEs
Description
Information regarding treatment emergent adverse events was collected during each dose cohort.
Time Frame
Up to 80 days
Title
Dose Proportionality of a single doses of CNTX-6016 in healthy subjects
Description
Dose Proportionality of a single doses of CNTX-6016 in healthy subjects.
Time Frame
40 days
Title
CNTX-6016 Pharmacokinetics - Cmax
Description
Systemic exposure to CNTX-6016 measured by Cmax.
Time Frame
Up to 40 days
Title
CNTX-6016 Pharmacokinetics - Tmax
Description
Systemic exposure to CNTX-6016 measured by Tmax.
Time Frame
Up to 40 days
Title
CNTX-6016 Pharmacokinetics - t1/2
Description
Systemic exposure to CNTX-6016 measured by t1/2.
Time Frame
Up to 40 days
Title
CNTX-6016 Pharmacokinetics - AUC 0-t
Description
Systemic exposure to CNTX-6016 measured by AUC 0-t.
Time Frame
Up to 40 days
Title
CNTX-6016 Pharmacokinetics - AUC 0-inf
Description
Systemic exposure to CNTX-6016 measured by AUC 0-inf.
Time Frame
Up to 40 days
Title
CNTX-6016 Pharmacokinetics - AUC 0-t/inf
Description
Systemic exposure to CNTX-6016 measured by AUC 0-t/inf.
Time Frame
Up to 40 days
Title
CNTX-6016 Pharmacokinetics - CL/F
Description
Systemic exposure to CNTX-6016 measured by CL/F.
Time Frame
Up to 40 days
Title
CNTX-6016 Pharmacokinetics - Vz/F
Description
Systemic exposure to CNTX-6016 measured by Vz/F.
Time Frame
Up to 40 days
Title
Effect of Gender on CNTX-6016 Pharmacokinetics - Cmax
Description
Effect of Gender on the systemic exposure to CNTX-6016 measured by Cmax.
Time Frame
Up to 80 days
Title
Effect of Gender on CNTX-6016 Pharmacokinetics - Tmax
Description
Effect of Gender on the systemic exposure to CNTX-6016 measured by tmax.
Time Frame
Up to 80 days
Title
Effect of Gender on CNTX-6016 Pharmacokinetics - t1/2
Description
Effect of Gender on the systemic exposure to CNTX-6016 measured by t1/2
Time Frame
Up to 80 days
Title
Effect of Gender on CNTX-6016 Pharmacokinetics - AUC
Description
Effect of Gender on the systemic exposure to CNTX-6016 measured by AUC.
Time Frame
Up to 80 days
Title
Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - Cmax
Description
Systemic exposure to CNTX-6016 in fasted or fed state as measured by Cmax
Time Frame
Up to 40 days
Title
Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - Tmax
Description
Systemic exposure to CNTX-6016 in fasted or fed state as measured by Tmax
Time Frame
Up to 40 days
Title
Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - t1/2
Description
Systemic exposure to CNTX-6016 in fasted or fed state as measured by t1/2
Time Frame
Up to 40 days
Title
Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - AUC
Description
Systemic exposure to CNTX-6016 in fasted or fed state as measured by AUC
Time Frame
Up to 40 days
Title
Urinary Excretion
Description
Urine was collected over a 3-day period (0-72 hrs) in Cohort 8 and analyzed for concentrations of CNTX-6016 in subjects in both the fasted and fed states using Liquid Chromatography Mass Spectrometry.
Time Frame
Up to 6 days
Secondary Outcome Measure Information:
Title
Plasma and Urine Metabolite Mining
Description
Urine was collected over a 3-day period (0-72hrs) in Cohort 9 (1000mg) and analyzed for concentrations of parent and metabolites of CNTX-6016 using Liquid Chromatography Mass Spectrometry.
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key Inclusion Criteria: Is in good general health as determined by Investigator's review. Has a body mass index (BMI) between 18 and 35 kg/m2. Non- or ex-smoker (> 1 year) and has not used any nicotine containing products within 12 months prior to screening. For females, is not currently pregnant 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: History of or active cardiac disease, including congestive heart failure, angina, or any arrhythmia. 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). Positive urine screen for alcohol, cotinine, THC and/or drugs of abuse. Ingestion of food or beverages containing grapefruit and/or grapefruit juice and/or pomelos during the 7 days prior to dosing and/or during the study period.
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
Altasciences Clinical Research
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Study to Evaluate the Safety and Pharmacokinetics of CNTX-6016 in Healthy Subjects

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