Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04154501
Recruitment Status : Completed
First Posted : November 6, 2019
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Centrexion Therapeutics

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

Condition or disease Intervention/treatment Phase
Chronic Pain Nociceptive Pain Pain Drug: CNTX-6016 Other: Other: Placebo Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Safety and Pharmacokinetics of Single Doses of CNTX-6016 in Healthy Subjects
Actual Study Start Date : December 4, 2018
Actual Primary Completion Date : August 21, 2019
Actual Study Completion Date : August 26, 2019

Arm Intervention/treatment
Placebo Comparator: Cohort 1 Placebo
Oral Placebo Capsule
Other: Other: Placebo
Oral Dose Placebo

Experimental: Cohort 1 Drug
25 mg Oral Capsule
Drug: CNTX-6016
Oral Dose CNTX-6016

Placebo Comparator: Cohort 2 Placebo
Oral Placebo Capsule
Other: Other: Placebo
Oral Dose Placebo

Experimental: Cohort 2 Drug
50 mg Oral Capsule
Drug: CNTX-6016
Oral Dose CNTX-6016

Placebo Comparator: Cohort 3 Placebo
Oral Placebo Capsule
Other: Other: Placebo
Oral Dose Placebo

Experimental: Cohort 3 Drug
100 mg Oral Capsule
Drug: CNTX-6016
Oral Dose CNTX-6016

Placebo Comparator: Cohort 4 Placebo
Oral Placebo Capsule
Other: Other: Placebo
Oral Dose Placebo

Experimental: Cohort 4 Drug
300 mg Oral Capsule
Drug: CNTX-6016
Oral Dose CNTX-6016

Placebo Comparator: Cohort 5 Placebo
Oral Placebo Capsule
Other: Other: Placebo
Oral Dose Placebo

Experimental: Cohort 5 Drug
450 mg Oral Capsule
Drug: CNTX-6016
Oral Dose CNTX-6016

Placebo Comparator: Cohort 6 Placebo
Oral Placebo Capsule
Other: Other: Placebo
Oral Dose Placebo

Experimental: Cohort 6 Drug
600 mg Oral Capsule
Drug: CNTX-6016
Oral Dose CNTX-6016

Placebo Comparator: Cohort 7 Placebo
Oral Placebo Capsule
Other: Other: Placebo
Oral Dose Placebo

Experimental: Cohort 7 Drug
800 mg Oral Capsule
Drug: CNTX-6016
Oral Dose CNTX-6016

Placebo Comparator: Cohort 9 Placebo
Oral Placebo Capsule
Other: Other: Placebo
Oral Dose Placebo

Experimental: Cohort 9 Drug
1000 mg Oral Capsule
Drug: CNTX-6016
Oral Dose CNTX-6016

Experimental: Cohort 8 Fasted
Participant will take 300 mg Oral Capsule in a fasting state, and then fed state.
Drug: CNTX-6016
Oral Dose CNTX-6016

Experimental: Cohort 8 Fed
Participant will take 300 mg Oral Capsule in a fed state, and then fasting state.
Drug: CNTX-6016
Oral Dose CNTX-6016




Primary Outcome Measures :
  1. Safety of single doses of CNTX-6016 - TEAEs [ Time Frame: Up to 80 days ]
    Information regarding treatment emergent adverse events was collected during each dose cohort.

  2. Dose Proportionality of a single doses of CNTX-6016 in healthy subjects [ Time Frame: 40 days ]
    Dose Proportionality of a single doses of CNTX-6016 in healthy subjects.

  3. CNTX-6016 Pharmacokinetics - Cmax [ Time Frame: Up to 40 days ]
    Systemic exposure to CNTX-6016 measured by Cmax.

  4. CNTX-6016 Pharmacokinetics - Tmax [ Time Frame: Up to 40 days ]
    Systemic exposure to CNTX-6016 measured by Tmax.

  5. CNTX-6016 Pharmacokinetics - t1/2 [ Time Frame: Up to 40 days ]
    Systemic exposure to CNTX-6016 measured by t1/2.

  6. CNTX-6016 Pharmacokinetics - AUC 0-t [ Time Frame: Up to 40 days ]
    Systemic exposure to CNTX-6016 measured by AUC 0-t.

  7. CNTX-6016 Pharmacokinetics - AUC 0-inf [ Time Frame: Up to 40 days ]
    Systemic exposure to CNTX-6016 measured by AUC 0-inf.

  8. CNTX-6016 Pharmacokinetics - AUC 0-t/inf [ Time Frame: Up to 40 days ]
    Systemic exposure to CNTX-6016 measured by AUC 0-t/inf.

  9. CNTX-6016 Pharmacokinetics - CL/F [ Time Frame: Up to 40 days ]
    Systemic exposure to CNTX-6016 measured by CL/F.

  10. CNTX-6016 Pharmacokinetics - Vz/F [ Time Frame: Up to 40 days ]
    Systemic exposure to CNTX-6016 measured by Vz/F.

  11. Effect of Gender on CNTX-6016 Pharmacokinetics - Cmax [ Time Frame: Up to 80 days ]
    Effect of Gender on the systemic exposure to CNTX-6016 measured by Cmax.

  12. Effect of Gender on CNTX-6016 Pharmacokinetics - Tmax [ Time Frame: Up to 80 days ]
    Effect of Gender on the systemic exposure to CNTX-6016 measured by tmax.

  13. Effect of Gender on CNTX-6016 Pharmacokinetics - t1/2 [ Time Frame: Up to 80 days ]
    Effect of Gender on the systemic exposure to CNTX-6016 measured by t1/2

  14. Effect of Gender on CNTX-6016 Pharmacokinetics - AUC [ Time Frame: Up to 80 days ]
    Effect of Gender on the systemic exposure to CNTX-6016 measured by AUC.

  15. Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - Cmax [ Time Frame: Up to 40 days ]
    Systemic exposure to CNTX-6016 in fasted or fed state as measured by Cmax

  16. Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - Tmax [ Time Frame: Up to 40 days ]
    Systemic exposure to CNTX-6016 in fasted or fed state as measured by Tmax

  17. Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - t1/2 [ Time Frame: Up to 40 days ]
    Systemic exposure to CNTX-6016 in fasted or fed state as measured by t1/2

  18. Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - AUC [ Time Frame: Up to 40 days ]
    Systemic exposure to CNTX-6016 in fasted or fed state as measured by AUC

  19. Urinary Excretion [ Time Frame: Up to 6 days ]
    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 :
  1. Plasma and Urine Metabolite Mining [ Time Frame: 5 days ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04154501


Locations
Layout table for location information
United States, Kansas
Altasciences Clinical Research
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
Centrexion Therapeutics
Investigators
Layout table for investigator information
Study Chair: Randall M Stevens, MD Centrexion Therapeutics
Layout table for additonal information
Responsible Party: Centrexion Therapeutics
ClinicalTrials.gov Identifier: NCT04154501    
Other Study ID Numbers: CNTX-6016o-HV-101
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centrexion Therapeutics:
Chronic Pain
Nociceptive Pain
Mixed Pain
Cannabinoid
Cannabinoid-2 Receptor Agonist
Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Pain
Nociceptive Pain
Pain
Neurologic Manifestations