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

• Status: Completed
• Trial end date: 2021-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Nanoform Finland Plc
• Treatments: Piroxicam

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• History of gastrointestinal disorders that predispose to bleeding disorders such as ulcerative colitis, Crohn's disease, gastrointestinal cancers or diverticulitis

• Subjects with active peptic ulcer, inflammatory gastrointestinal disorder or gastrointestinal bleeding

• Subjects with a history of cholecystectomy or gall stones

• History of adverse reactions or allergy associated with any drug

• Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients

• History of previous serious allergic drug reaction of any type, especially cutaneous reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis

• Previous skin reaction (regardless of severity) to piroxicam, other NSAIDs and other medications

• Subjects in whom aspirin and other NSAIDs induce the symptoms of asthma, nasal polyps, angioedema or urticaria

• Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active

• Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood

• Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4 g of paracetamol per day or hormonal replacement therapy [HRT]/hormonal contraception) in the 14 days before IMP administration. Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as determined by the investigator

• Concomitant use of other NSAIDs, including cyclooxygenase-2 inhibitors, selective NSAIDs and acetylsalicylic acid at analgesic doses

• Failure to satisfy the investigator of fitness to participate for any other reason