Clinical trial NCT04154501: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Pain
Nociceptive Pain
Pain
Keywords: Chronic Pain
Nociceptive Pain
Mixed Pain
Cannabinoid
Cannabinoid-2 Receptor Agonist
Lead sponsor: Centrexion Therapeutics
Sponsor class: INDUSTRY
First posted: 2019-11-06
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Safety of single doses of CNTX-6016 - TEAEs
timeFrame: Up to 80 days
measure: Dose Proportionality of a single doses of CNTX-6016 in healthy subjects
timeFrame: 40 days
measure: CNTX-6016 Pharmacokinetics - Cmax
timeFrame: Up to 40 days
measure: CNTX-6016 Pharmacokinetics - Tmax
timeFrame: Up to 40 days
measure: CNTX-6016 Pharmacokinetics - t1/2
timeFrame: Up to 40 days
measure: CNTX-6016 Pharmacokinetics - AUC 0-t
timeFrame: Up to 40 days
measure: CNTX-6016 Pharmacokinetics - AUC 0-inf
timeFrame: Up to 40 days
measure: CNTX-6016 Pharmacokinetics - AUC 0-t/inf
timeFrame: Up to 40 days
measure: CNTX-6016 Pharmacokinetics - CL/F
timeFrame: Up to 40 days
measure: CNTX-6016 Pharmacokinetics - Vz/F
timeFrame: Up to 40 days
measure: Effect of Gender on CNTX-6016 Pharmacokinetics - Cmax
timeFrame: Up to 80 days
measure: Effect of Gender on CNTX-6016 Pharmacokinetics - Tmax
timeFrame: Up to 80 days
measure: Effect of Gender on CNTX-6016 Pharmacokinetics - t1/2
timeFrame: Up to 80 days
measure: Effect of Gender on CNTX-6016 Pharmacokinetics - AUC
timeFrame: Up to 80 days
measure: Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - Cmax
timeFrame: Up to 40 days
measure: Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - Tmax
timeFrame: Up to 40 days
measure: Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - t1/2
timeFrame: Up to 40 days
measure: Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - AUC
timeFrame: Up to 40 days
measure: Urinary Excretion
timeFrame: Up to 6 days
Secondary outcomes:
measure: Plasma and Urine Metabolite Mining
timeFrame: 5 days
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Altasciences Clinical Research
state: Kansas
Study officials:
affiliation: Centrexion Therapeutics
name: Randall M Stevens, MD
role: STUDY_CHAIR
References: