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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04154501
Other study ID # CNTX-6016o-HV-101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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