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A Phase 1 Study to Evaluate EMP22 PD and EMP16 PK Versus Xenical® in Healthy Volunteers

Primary Purpose

Overweight or Obesity

Status
Recruiting
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
Xenical® vs EMP 22
EMP 22 vs Xenical®
EMP 16 vs Xenical®
Sponsored by
Empros Pharma AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Overweight or Obesity focused on measuring Overweight, Obesity

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Criteria: 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. 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. Any planned major surgery within the duration of the trial. Participants who are pregnant, currently breastfeeding, or intend to become pregnant during the course of the trial. Any positive result at the screening visit for serum hepatitis B surface antigen, hepatitis C antibodies and/or human immunodeficiency virus (HIV). 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. 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. 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. 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. Positive screening result for drugs of abuse or alcohol at the screening visit. 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. 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. Plasma donation within 1 month of screening or blood donation (or corresponding blood loss) during the last 3 months prior to screening. The Investigator considers the participant unlikely to comply with trial procedures, restrictions and requirements.

Sites / Locations

  • CTC Clinical Trial Consultanta ABRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Xenical - EMP22 part 1 crossover blinded

EMP22 - Xenical part 1 crossover blinded

EMP16 - Xenical part 2 sequential open label

Arm Description

After a 5-day diet run-in period, orlistat in its conventional form (Xenical®, 120 mg orlistat) will be taken 3 times daily (ter in die [TID]) together with the 3 main daily meals for a 9-day treatment period. After a 4-to-14-day wash-out period; EMP22 (120 mg modified release orlistat) will be taken TID together with the 3 main daily meals for a 9-day treatment period.

After a 5-day diet run-in period, EMP22 (120 mg modified release orlistat) will be taken 3 times daily (ter in die [TID]) together with the 3 main daily meals for a 9-day treatment period. After a 4-to-14-day wash-out period; orlistat in its conventional form (Xenical®, 120 mg orlistat) will be taken TID together with the 3 main daily meals for a 9-day treatment period.

Single dose of EMP16 (120 mg orlistat/40 mg acarbose) will be taken together with breakfast during one PK study day. After a 4-to-14-day wash-out period, Xenical® (120 mg orlistat) will be taken together with breakfast during one PK study day.

Outcomes

Primary Outcome Measures

The percent of faecal fat
The percent of faecal fat excretion expressed as a ratio of the amount of fat excretion over a 24-hour period at steady-state relative to the amount of daily ingested fat.

Secondary Outcome Measures

Cmax - to explore the PK properties of EMP16
Cmax for orlistat and acarbose
Tmax - to explore the PK properties of EMP16
Tmax for orlistat and acarbose
AUC0-t - to explore the PK properties of EMP16
AUC0-t for orlistat and acarbose
Cmax - to compare the bioavailability of orlistat in EMP16 and Xenical®
Cmax for orlistat
Tmax - to compare the bioavailability of orlistat in EMP16 and Xenical®
Tmax for orlistat
AUC0-t - to compare the bioavailability of orlistat in EMP16 and Xenical®
AUC0-t for orlistat

Full Information

First Posted
August 22, 2023
Last Updated
October 2, 2023
Sponsor
Empros Pharma AB
Collaborators
CTC Clinical Trial Consultants AB
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1. Study Identification

Unique Protocol Identification Number
NCT06013163
Brief Title
A Phase 1 Study to Evaluate EMP22 PD and EMP16 PK Versus Xenical® in Healthy Volunteers
Official Title
Control Of BioEquivalence With Xenical (COBEX): A Phase I, Randomised, Active-control Study to Evaluate EMP22 Pharmacodynamics and EMP16 Pharmacokinetics Versus Xenical® in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Empros Pharma AB
Collaborators
CTC Clinical Trial Consultants AB

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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 fecal 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. Healthy volunteers will be recruited to the trial.
Detailed Description
Approximately 35 participants are planned to be screened to achieve 20 randomised participants and at least 16 evaluable participants in Part I. All participants who complete Part I will continue in Part II. Each participant is expected to participate in the trial for approximately 9 to 13 weeks (depending on the length of each wash-out period), including a 28-day screening period. Part I: Participants will self-administer EMP22 for 9 days and Xenical® for 9 days (TID dosing) at home. EMP22 and Xenical® should be taken halfway through each of the 3 main meals during the day (breakfast, lunch, dinner) with approximately 50 to 200 mL water. EMP22 and Xenical® have different strengths of orlistat, 60 mg and 120 mg, respectively. In order to maintain the blind for the participants, the IMP will be administered as follows: EMP22 60 mg orlistat, 2 capsules TID. Xenical® 120 mg orlistat 1 capsule + placebo 1 capsule TID. Part II: Following an overnight fast of at least 8 hours and a light standardised breakfast upon admission (approximately 2 hours prior to dose), EMP16 will be taken halfway through a regular standardised breakfast (5 minutes after the start of the meal, which is expected to be finished in 10 minutes) with approximately 50 to 200 mL water. After a 4-14 day washout, the same procedure will be repeated using Xenical® . The participants will receive a single dose dose of EMP16 (2 capsules, each of 60 mg) and a single dose of Xenical® (1 capsule, 120 mg).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight or Obesity
Keywords
Overweight, Obesity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
In Part I (single-blind), EMP22 (120 mg orlistat) and orlistat in its conventional form (Xenical®, 120 mg orlistat) will be taken 3 times daily (ter in die [TID]) together with the 3 main daily meals for two 9-day treatment periods in a cross-over manner. In Part II (open-label), single doses of EMP16 (120 mg orlistat/40 mg acarbose) and Xenical® (120 mg orlistat) will be taken together with breakfast on 2 separate days.
Masking
Participant
Masking Description
Part I: EMP22 and Xenical® have different strengths of orlistat, 60 mg and 120 mg, respectively. In order to maintain the blind, the IMP will be administered as follows: EMP22 60 mg orlistat, 2 capsules TID. Xenical® 120 mg orlistat 1 capsule + placebo 1 capsule TID. EMP22, Xenical® and placebo will be identical in appearance. Part II will be open-label, i.e., the Investigator, trial staff and trial participants will know which treatment, EMP16 or Xenical®, that is given at each visit.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Xenical - EMP22 part 1 crossover blinded
Arm Type
Active Comparator
Arm Description
After a 5-day diet run-in period, orlistat in its conventional form (Xenical®, 120 mg orlistat) will be taken 3 times daily (ter in die [TID]) together with the 3 main daily meals for a 9-day treatment period. After a 4-to-14-day wash-out period; EMP22 (120 mg modified release orlistat) will be taken TID together with the 3 main daily meals for a 9-day treatment period.
Arm Title
EMP22 - Xenical part 1 crossover blinded
Arm Type
Active Comparator
Arm Description
After a 5-day diet run-in period, EMP22 (120 mg modified release orlistat) will be taken 3 times daily (ter in die [TID]) together with the 3 main daily meals for a 9-day treatment period. After a 4-to-14-day wash-out period; orlistat in its conventional form (Xenical®, 120 mg orlistat) will be taken TID together with the 3 main daily meals for a 9-day treatment period.
Arm Title
EMP16 - Xenical part 2 sequential open label
Arm Type
Active Comparator
Arm Description
Single dose of EMP16 (120 mg orlistat/40 mg acarbose) will be taken together with breakfast during one PK study day. After a 4-to-14-day wash-out period, Xenical® (120 mg orlistat) will be taken together with breakfast during one PK study day.
Intervention Type
Drug
Intervention Name(s)
Xenical® vs EMP 22
Other Intervention Name(s)
Part I
Intervention Description
Each participant will first use Xenical® TID for 9 days and then EMP22TID for 9 days (in total 27 doses of each drug).
Intervention Type
Drug
Intervention Name(s)
EMP 22 vs Xenical®
Other Intervention Name(s)
Part I
Intervention Description
Each participant will first use EMP22 TID for 9 days and then Xenical® TID for 9 days (in total 27 doses of each drug).
Intervention Type
Drug
Intervention Name(s)
EMP 16 vs Xenical®
Other Intervention Name(s)
Part II
Intervention Description
Each participant will receive a single dose of EMP16 and then a single dose of Xenical®.
Primary Outcome Measure Information:
Title
The percent of faecal fat
Description
The percent of faecal fat excretion expressed as a ratio of the amount of fat excretion over a 24-hour period at steady-state relative to the amount of daily ingested fat.
Time Frame
Day -2 , Day -1 , and between the morning of Day 9 and Day 10.
Secondary Outcome Measure Information:
Title
Cmax - to explore the PK properties of EMP16
Description
Cmax for orlistat and acarbose
Time Frame
12 hour for each day of treatment
Title
Tmax - to explore the PK properties of EMP16
Description
Tmax for orlistat and acarbose
Time Frame
12 hour for each day of treatment
Title
AUC0-t - to explore the PK properties of EMP16
Description
AUC0-t for orlistat and acarbose
Time Frame
12 hour for each day of treatment
Title
Cmax - to compare the bioavailability of orlistat in EMP16 and Xenical®
Description
Cmax for orlistat
Time Frame
12 hour for each day of treatment
Title
Tmax - to compare the bioavailability of orlistat in EMP16 and Xenical®
Description
Tmax for orlistat
Time Frame
12 hour for each day of treatment
Title
AUC0-t - to compare the bioavailability of orlistat in EMP16 and Xenical®
Description
AUC0-t for orlistat
Time Frame
12 hour for each day of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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. 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. Any planned major surgery within the duration of the trial. Participants who are pregnant, currently breastfeeding, or intend to become pregnant during the course of the trial. Any positive result at the screening visit for serum hepatitis B surface antigen, hepatitis C antibodies and/or human immunodeficiency virus (HIV). 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. 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. 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. 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. Positive screening result for drugs of abuse or alcohol at the screening visit. 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. 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. Plasma donation within 1 month of screening or blood donation (or corresponding blood loss) during the last 3 months prior to screening. The Investigator considers the participant unlikely to comply with trial procedures, restrictions and requirements.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ulf Holmbäck, PhD
Phone
+4670 173 00 41
Email
ulf.holmback@emprospharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ulf Holmbäck
Phone
+4670 173 00 41
Email
ulf.holmback@emprospharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulf Holmbäck
Organizational Affiliation
Empros Pharma
Official's Role
Study Chair
Facility Information:
Facility Name
CTC Clinical Trial Consultanta AB
City
Uppsala
ZIP/Postal Code
752 37
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helena Litorp, MD, PhD
Phone
+46 (0)72 225 00 75
Email
helena.litorp@ctc-ab.se
First Name & Middle Initial & Last Name & Degree
Helena Litorp, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

A Phase 1 Study to Evaluate EMP22 PD and EMP16 PK Versus Xenical® in Healthy Volunteers

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