Control Of BioEquivalence with Xenical (COBEX): A Phase I, randomized, active-control study to evaluate EMP22 pharmacodynamics and EMP16 pharmacokinetics versus Xenical® in healthy volunteers.

Trial details

Who runs it

Empros Pharma AB

Trial code

EU 2023-505671-74-00

Record updated

2023. szeptember 1.

Original description

To confirm the PD equivalence of the MR orlistat component of EMP16 (i.e., EMP22) and Xenical® (Part I).Read full original descriptionShow less

To confirm the PD equivalence of the MR orlistat component of EMP16 (i.e., EMP22) and Xenical® (Part I).

This Phase I, active-controlled, randomised trial will be conducted in 2 parts. Part I aims to confirm the PD equivalence of EMP22 and Xenical® based on percent faecal fat excretion at steady state. EMP22 (also referred to as MR orlistat) has the same MR properties as EMP16 but lacks the acarbose component. Part II will explore the PK properties of EMP16 alone and vs. Xenical®. Part I will be conducted in a single-blind, cross-over fashion while Part II will have an open-label, fixed-sequence design.

Inclusion: Willing and able to give written informed consent for participation in the trial; Healthy male or female aged 20 to 55 years inclusive; Participants with a BMI between 20 and 27 kg/m² or participants with a BMI >27 kg/m2 and normal body fat composition (10 to 25% for men and 20 to 30% for women measured using a bioimpedance scale) at screening; Weight stable (<5% self-reported change during the previous 3 months preceding screening); Participants with a self-perceived normality in defecation habits, normally with a stool frequency of at least once daily; Medically healthy participant without abnormal clinically significant medical history, physical findings, vital signs, electrocardiogram (ECG) and laboratory values at the time of the screening visit, as judged by the Investigator.

Exclusion: History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or influence the results or the participant’s ability to participate in the trial including but not limited to: • GI problems/diseases, e.g. inflammatory bowel diseases and irritable bowel syndrome (IBS). • Cholestasis. • Previous GI surgery that might influence GI function significantly, such as previous bariatric surgery, and previous gallbladder surgery as judged by the investigator. • Vitamin B12 deficiency or other signs of achlorhydria. • Chronical malabsorption syndrome. • History of severe allergic, cardiac or hepatic disease; Administration of another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical trial that included drug treatment within 3 months of the first administration of IMP in this trial. Subjects consented and screened but not dosed in previous studies are not excluded; Positive screening result for drugs of abuse or alcohol at the screening visit; Plasma donation within 1 month of screening or blood donation (or corresponding blood loss) during the last 3 months prior to screening; Any planned major surgery within the duration of the trial; Regular use of any prescribed or non-prescribed medications (including, but not limited to, antacids, analgesics, herbal remedies, vitamins and minerals) within 2 weeks prior to the first administration of IMP except as outlined in Section 9.6.2.3. in the Protocol; History of alcohol abuse or excessive intake of alcohol, as judged by the Investigator; Presence or history of drug abuse, as judged by the Investigator; History of, or current use of anabolic steroids, as judged by the Investigator; Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP; Malignancy within the past 5 years, with the exception of in situ removal of basal cell carcinoma; Prolonged QTcF (>450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG at the screening visit, as judged by the Investigator; History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class as orlistat or acarbose; Any positive result at the screening visit for serum hepatitis B surface antigen, hepatitis C antibodies and/or human immunodeficiency virus (HIV); Current smokers or users of nicotine products. Irregular use of nicotine (e.g., smoking, snuffing, chewing tobacco) less than 3 times/week is allowed before the screening visit; Excessive caffeine consumption defined by a daily intake of > 5 cups (1 cup = approximately 240 mL) of caffeine containing beverages, as judged by the Investigator; The Investigator considers the participant unlikely to comply with trial procedures, restrictions and requirements; Participants who are pregnant, currently breastfeeding, or intend to become pregnant during the course of the trial.

EU CTIS 2023-505671-74-00