PK Evaluation of a Nanoformed Oral IR Piroxicam Tablet in Healthy Subjects

NCT05104931 | Completed Phase 1

• 1 other identifier: UNICORN
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Piroxicam is a nonsteroidal anti-inflammatory medication and currently used to treat pain and inflammation caused by osteoarthritis or rheumatoid arthritis. The aim of this study is to study the pharmacokinetic behaviour of the new nanoformed 20mg tablet formulation of piroxicam in comparison with a reference 20mg piroxicam tablet formulation. The target of nanoforming is to improve the pharmacokinetic properties of drugs with low solubility, potentially leading to the use of lower doses with concomitant improvements in safety and tolerability. Piroxicam is an appropriate candidate to demonstrate the benefits of nanoforming due to its physiochemical properties. The efficacy of the Nanoformed Piroxicam is evaluated in comparison to the reference product Felden® Tabs 20 mg. The study also is conducted with a second reference product, Brexidol® 20 mg, or a nanoformed piroxicam tablet of a different strength, or study the effect of food intake on the absorption of the nanofomed piroxicam tablet. The study is conducted with healthy volunteers.

Conditions

Pain

Outcome Measures

Primary Outcomes (3)

• To determine the Maximum Plasma Concentration (Cmax) of piroxicam following administration of single oral doses of Nanoformed Piroxicam IR Tablet 5 - 20 mg and Felden (piroxicam) Tablets 20mg (reference) in healthy subjects in the fasted state.

  To determine the pharmacokinetics and relative bioavailability of piroxicam over a 72h period following administration of single oral doses of Nanoformed Piroxicam IR Tablet 5 - 20 mg and Felden (piroxicam) Tablets 20mg (reference) in healthy subjects in the fasted state by determining the Maximum Plasma Concentration (Cmax).

  72 hours

• To determine the Area Under the drug Concentration of piroxicam following administration of single oral doses of Nanoformed Piroxicam IR Tablet 5 - 20 mg and Felden (piroxicam) Tablets 20mg (reference) in healthy subjects in the fasted state.

  To determine the pharmacokinetics and relative bioavailability of piroxicam over a 72h period following administration of single oral doses of Nanoformed Piroxicam IR Tablet 5 - 20 mg and Felden (piroxicam) Tablets 20mg (reference) in healthy subjects in the fasted state by determining the Area Under the drug Concentration time curve over 1 hour (AUC(0 1h)), AUC from time 0 to the time of last measurable concentration (AUC(0 last)) and AUC from time 0 extrapolated to infinity (AUC(0-inf)).

  72 hours

• To determine the time to Cmax (Tmax) of piroxicam following administration of single oral doses of Nanoformed Piroxicam IR Tablet 5 - 20 mg and Felden (piroxicam) Tablets 20mg (reference) in healthy subjects in the fasted state.

  To determine the pharmacokinetics and relative bioavailability of piroxicam over a 72h period following administration of single oral doses of Nanoformed Piroxicam IR Tablet 5 - 20 mg and Felden (piroxicam) Tablets 20mg (reference) in healthy subjects in the fasted state by determining the time to Cmax (Tmax).

  72 hours

Secondary Outcomes (4)

• Number of participants that report adverse events (AEs) coded using MedDRA v23.1, pre-dose and 48-72h post-dose, for determining safety and tolerability.

  72 hours

• To assess additional safety and tolerability information for piroxicam following administration of single oral doses of Nanoformed Piroxicam IR Tablet, 5 - 20mg in healthy subjects by assessing and reporting supine electrocardiograms

  72 hours

• To assess additional safety and tolerability information for piroxicam following administration of single oral doses of Nanoformed Piroxicam IR Tablet, 5 - 20mg in healthy subjects by assessing and reporting supine electrocardiograms

  72 hours

• To assess additional safety and tolerability information for piroxicam following administration of single oral doses of Nanoformed Piroxicam IR Tablet, 5 - 20mg in healthy subjects by assessing and reporting supine electrocardiograms

  72 hours

Study Arms (3)

Nanoformed Piroxicam IR Tablet

EXPERIMENTAL

orally delivered nanoformed piroxicam immediate release tablets (20mg)

Drug: Nanoformed Piroxicam IR Tablet

Felden (piroxicam) Tablets

ACTIVE COMPARATOR

orally delivered Felden (piroxicam) tablets (20mg)

Drug: Felden (piroxicam) Tablets

Brexidol (piroxicam) Tablets

ACTIVE COMPARATOR

orally delivered Brexidol (piroxicam) tablets (20mg)

Drug: Nanoformed Piroxicam IR Tablet; Drug: Brexidol (piroxicam) Tablets

Interventions

Nanoformed Piroxicam IR Tablet DRUG

Orally delivered Nanoformed Piroxicam

Also known as: Orally delivered Nanoformed Piroxicam IR tablet

Brexidol (piroxicam) Tablets; Nanoformed Piroxicam IR Tablet

Felden (piroxicam) Tablets DRUG

orally delivered Felden (reference) tablets

Also known as: orally delivered Felden (piroxicam) tablets

Felden (piroxicam) Tablets

Brexidol (piroxicam) Tablets DRUG

orally delivered Brexidol (reference) tablets

Also known as: orally delivered Brexidol (piroxicam) tablets

Brexidol (piroxicam) Tablets

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males or non-pregnant, non-lactating healthy females
• Aged 18 to 55 years inclusive at the time of signing informed consent
• Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening
• Must be willing and able to communicate and participate in the whole study
• Must provide written informed consent
• Must agree to adhere to the contraception requirements

You may not qualify if:

• Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1
• Subjects who are, or are immediate family members of, a study site or sponsor employee
• Evidence of current SARS-CoV-2 infection
• History of any drug or alcohol abuse in the past 2 years
• Regular alcohol consumption in males \>21 units per week and females \>14 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type)
• A confirmed positive alcohol breath test at screening or admission
• Current smokers and those who have smoked within the last 12 months. A positive urine cotinine test at screening or admission
• Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
• Females who are pregnant or lactating (all female subjects must have a negative urine pregnancy test)
• Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening
• Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator
• Confirmed positive drugs of abuse test result
• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results
• History of clinically significant cardiovascular (including ischaemic heart disease, peripheral arterial disease, heart failure), renal, hepatic, dermatological, chronic respiratory (including asthma) or neurological or psychiatric disorder, as judged by the investigator
• History of gastro-intestinal ulceration, bleeding or perforation

Sponsors & Collaborators

• Nanoform Finland Plc: lead

Study Sites (1)

Quotient Sciences

Nottingham, NG11 6JS, United Kingdom

Location

MeSH Terms

Conditions

Pain

Interventions

Piroxicam; Tablets

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Philip Evans, MBChB

  Quotient Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2021
• First Posted: November 3, 2021
• Study Start: December 2, 2020
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: November 3, 2021

Record last verified: 2021-10

Locations

GB (1)