Bioavailability and Safety Study Comparing Two Dose Levels of AMZ001 and One Dose Level of Diclofenac Sodium 1% Gel in Healthy Participants
- Conditions
- Healthy
- Registration Number
- NCT05968482
- Lead Sponsor
- Amzell
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 74
Inclusion Criteria:<br><br> - Healthy male or female participants 18-65 years of age (e.g., in general good<br> physical health, as judged by the Investigator and no clinically relevant<br> abnormalities identified by a detailed medical history, full physical examination,<br> including blood pressure and pulse rate measurement, 12-lead ECG (electrocardiogram)<br> or clinical laboratory tests)<br><br> - Has a body mass index (BMI) between 18.0 and 35.0 kg/m^2 (kilogram per square meter)<br> at Screening.<br><br> - In the case of females of child-bearing potential ([FCBP) unless surgically<br> sterilized [hysterectomy, bilateral oophorectomy, bilateral tubal ligation] or are<br> postmenopausal for at least 12 months), are using two acceptable forms of birth<br> control (hormonal contraceptives i.e., oral/implant/injectable/transdermal;<br> intrauterine device (IUD) and/or barrier methods [female condom, male condom,<br> diaphragm, cervical cap, spermicide]; note: 2 barrier methods are two acceptable<br> forms of birth control)). Abstinence or partner's vasectomies are acceptable if the<br> female participant agrees to implement two acceptable forms of birth control if her<br> lifestyle/partner changes.<br><br> - Females of child-bearing potential have a negative serum pregnancy test (SPT) at<br> Screening and negative urine pregnancy test (UPT) on Day -1 of each period and at<br> end of treatment (EOT) visit<br><br> - Are free of any systemic or dermatologic disorder and chronic or acute infections,<br> which, in the opinion of the Principal Investigator (PI), will interfere with the<br> study results or increase the risk of adverse events (AEs)<br><br> - Read, understand, and provide signed informed consent before any assessment is<br> performed.<br><br>Exclusion Criteria:<br><br> - Participant has any visible skin disease, skin lesions, wounds, or a significant<br> amount of hair at the application site (knee)<br><br> - Use of an investigational medicinal product (IMP) within 30 days or 5 half-lives (if<br> known), whichever is longer, of enrollment or during the study.<br><br> - Treated with systemic or local diclofenac within 30 days of enrollment or during the<br> study (except for study IMP)<br><br> - Known hypersensitivity to diclofenac, aspirin, Xarelto, coumadin, or other<br> non-steroidal anti-inflammatory drugs (NSAIDs), including Cyclooxygenase-2 (COX-2)<br> inhibitors.<br><br> - Any history of drug hypersensitivity, asthma, urticaria, or other significant<br> allergic diathesis. Participants with uncomplicated seasonal allergic rhinitis can<br> be accepted only if the expected allergy season is clearly outside enrollment /<br> treatment periods.<br><br> - Females who are pregnant and/or lactating<br><br> - Of child-bearing potential but not willing to use adequate contraception for the<br> duration of the study<br><br> - Participant is a current smoker and unable to abstain from smoking during the<br> treatment periods.<br><br> - Use of any topical medication, cosmetics, cream, ointments, lotions on the treatment<br> site 1 week prior to enrollment through EOT visit<br><br> - Use of any medication (including over-the-counter medication, dietary supplements,<br> and herbal remedies) within 2 weeks before first scheduled study drug administration<br> or within less than 5 times the elimination half-life of the respective drug<br> (whichever is longer) or is anticipated to require concomitant medication during the<br> 2-week period or at any time throughout the study. Consumption of any drug<br> metabolizing enzyme (e.g., cytochrome P450 3A4 (CYP3A4) or other cytochrome P450<br> enzymes) inducing or inhibiting beverages or food (e.g., broccoli, Brussel sprouts,<br> grapefruit, grapefruit juice, star fruit) within 3 days prior to and during each<br> treatment period<br><br> - Participant has a known or suspected malignancy, excluding basal cell cancer unless<br> it is associated with the treatment area.<br><br> - Participant has a positive blood screen for human immunodeficiency virus (HIV),<br> hepatitis B surface antigen (HBsAg), hepatitis C antibody (Anti-HCV)<br><br> - Participant has any acute or chronic condition or is using medications, which, in<br> the investigator's opinion, would make it unsafe for the participant to participate<br> in this study, including clinically significant abnormal laboratory values, vital<br> signs, physical examination findings prior to randomization or during study<br> participation.<br><br> - History or current evidence of renal disease or impaired renal function at screening<br> as indicated by abnormal levels of serum creatinine (greater than (>) 1.43 mg/dL<br> (milligram per deciliter)) or blood urea nitrogen (greater than or equal to (=) 35<br> mg/dL) or the presence of clinical significant abnormal urinary constituents (e.g.,<br> albuminuria)<br><br> - History or current evidence of ongoing hepatic disease or impaired hepatic function<br> at screening. A participant will be excluded if more than one of the following lab<br> value deviations are found: 1) aspartate aminotransferase (AST) (= 1.5 upper limit<br> of normal (ULN)), alanine aminotransferase (ALT) (= 1.5 ULN), 2) Gamma-Glutamyl<br> Transferase (GGT) (= 1.5 ULN), alkaline phosphatase (ALP) (= 1.5 ULN), 3) total<br> bilirubin (> 2.00 mg/dL) or creatine kinase (= 3 ULN). A single deviation from the<br> above values is acceptable and will not exclude the participant, unless specifically<br> advised by the Investigator.<br><br> - Participant has clinically relevant chronic or acute infectious illnesses or febrile<br> infections within 2 weeks prior to the first scheduled study drug administration<br><br> - Participant has gastrointestinal bleeding issues, e.g., Gastroesophageal Reflux<br> Disease (GERD), Peptic Ulcer Disease (PUD)<br><br> - Participant has a hospital admission or major surgery within 30 days prior to<br> randomization.<br><br> - Participant has a donation or blood collection of more than 1 unit (approximately<br> 450 mL(milliliter)) of blood (or blood products) or acute loss of blood during the<br> 30 days prior to randomization.<br><br> - Participant has a history of alcohol abuse, prescription drug abuse, or illicit drug<br> use within 6 months prior to Screening.<br><br> - Participant meets eligibility criteria, but study is filled<br><br> - Participant who is an investigational site staff member directly involved in the<br> conduct of the study and his/her family members, site staff member otherwise<br> supervised by the Investigator, or participant who is a Amzell B.V. employee<br> directly involved in the conduct of the study
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Compare exposure to diclofenac
- Secondary Outcome Measures
Name Time Method Pharmacokinetic parameter - Cmin;Pharmacokinetic parameter - Tmax;Pharmacokinetic parameter - Ke;Pharmacokinetic parameter - Cavg;Pharmacokinetic parameter - Cmax;Pharmacokinetic parameter - Tmax;Pharmacokinetic parameter - Cavg;Local tolerability