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

A Study to Evaluate the Safety and Pharmacokinetics of Single Doses 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.

Study Overview

• Status: Completed
• Conditions: Pain; Chronic Pain; Nociceptive Pain
• Intervention / Treatment: Other: Other: Placebo; Drug: CNTX-6016

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Altasciences Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

18

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of single doses of CNTX-6016 - TEAEs	Information regarding treatment emergent adverse events was collected during each dose cohort.	Up to 80 days
Dose Proportionality of a single doses of CNTX-6016 in healthy subjects	Dose Proportionality of a single doses of CNTX-6016 in healthy subjects.	40 days
CNTX-6016 Pharmacokinetics - Cmax	Systemic exposure to CNTX-6016 measured by Cmax.	Up to 40 days
CNTX-6016 Pharmacokinetics - Tmax	Systemic exposure to CNTX-6016 measured by Tmax.	Up to 40 days
CNTX-6016 Pharmacokinetics - t1/2	Systemic exposure to CNTX-6016 measured by t1/2.	Up to 40 days
CNTX-6016 Pharmacokinetics - AUC 0-t	Systemic exposure to CNTX-6016 measured by AUC 0-t.	Up to 40 days
CNTX-6016 Pharmacokinetics - AUC 0-inf	Systemic exposure to CNTX-6016 measured by AUC 0-inf.	Up to 40 days
CNTX-6016 Pharmacokinetics - AUC 0-t/inf	Systemic exposure to CNTX-6016 measured by AUC 0-t/inf.	Up to 40 days
CNTX-6016 Pharmacokinetics - CL/F	Systemic exposure to CNTX-6016 measured by CL/F.	Up to 40 days
CNTX-6016 Pharmacokinetics - Vz/F	Systemic exposure to CNTX-6016 measured by Vz/F.	Up to 40 days
Effect of Gender on CNTX-6016 Pharmacokinetics - Cmax	Effect of Gender on the systemic exposure to CNTX-6016 measured by Cmax.	Up to 80 days
Effect of Gender on CNTX-6016 Pharmacokinetics - Tmax	Effect of Gender on the systemic exposure to CNTX-6016 measured by tmax.	Up to 80 days
Effect of Gender on CNTX-6016 Pharmacokinetics - t1/2	Effect of Gender on the systemic exposure to CNTX-6016 measured by t1/2	Up to 80 days
Effect of Gender on CNTX-6016 Pharmacokinetics - AUC	Effect of Gender on the systemic exposure to CNTX-6016 measured by AUC.	Up to 80 days
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	Up to 40 days
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	Up to 40 days
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	Up to 40 days
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	Up to 40 days
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.	Up to 6 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 days

Collaborators and Investigators

• Sponsor: Centrexion Therapeutics
• Investigators: Study Chair: Randall M Stevens, MD, Centrexion Therapeutics

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 4, 2018
• Primary Completion (ACTUAL): August 21, 2019
• Study Completion (ACTUAL): August 26, 2019

Study Registration Dates

• First Submitted: October 7, 2019
• First Submitted That Met QC Criteria: November 4, 2019
• First Posted (ACTUAL): November 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 6, 2019
• Last Update Submitted That Met QC Criteria: November 4, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Chronic Pain; Cannabinoid; Nociceptive Pain; Mixed Pain; Cannabinoid-2 Receptor Agonist
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Nociceptive Pain
• Other Study ID Numbers: CNTX-6016o-HV-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No