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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04154501
• Other study ID #: CNTX-6016o-HV-101
• Status: Completed
• Phase: Phase 1
• Start date: December 4, 2018
• Est. completion date: August 26, 2019

Study information

• Verified date: November 2019
• Source: Centrexion Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: August 26, 2019
• Est. primary completion date: August 21, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Nociceptive Pain
• Pain

Intervention

Drug:
• CNTX-6016
Oral Dose CNTX-6016

Other:
• Other: Placebo
Oral Dose Placebo

Locations

Country	Name	City	State
United States	Altasciences Clinical Research	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Centrexion Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of single doses of CNTX-6016 - TEAEs	Information regarding treatment emergent adverse events was collected during each dose cohort.	Up to 80 days
Primary	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
Primary	CNTX-6016 Pharmacokinetics - Cmax	Systemic exposure to CNTX-6016 measured by Cmax.	Up to 40 days
Primary	CNTX-6016 Pharmacokinetics - Tmax	Systemic exposure to CNTX-6016 measured by Tmax.	Up to 40 days
Primary	CNTX-6016 Pharmacokinetics - t1/2	Systemic exposure to CNTX-6016 measured by t1/2.	Up to 40 days
Primary	CNTX-6016 Pharmacokinetics - AUC 0-t	Systemic exposure to CNTX-6016 measured by AUC 0-t.	Up to 40 days
Primary	CNTX-6016 Pharmacokinetics - AUC 0-inf	Systemic exposure to CNTX-6016 measured by AUC 0-inf.	Up to 40 days
Primary	CNTX-6016 Pharmacokinetics - AUC 0-t/inf	Systemic exposure to CNTX-6016 measured by AUC 0-t/inf.	Up to 40 days
Primary	CNTX-6016 Pharmacokinetics - CL/F	Systemic exposure to CNTX-6016 measured by CL/F.	Up to 40 days
Primary	CNTX-6016 Pharmacokinetics - Vz/F	Systemic exposure to CNTX-6016 measured by Vz/F.	Up to 40 days
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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