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OpenTrials
Completed

NCT Number: NCT04154501

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

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

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Altasciences Clinical Research

Overland Park, Kansas, 66212, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CNTX-6016

Drug

Oral Dose CNTX-6016

Other: Placebo

Other

Oral Dose Placebo

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Centrexion Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 6, 2019
Registry last updated
Nov 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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