Evaluation of Apraglutide on Gastric Emptying
Study Details
Study Description
Brief Summary
The primary objective is to assess the effect of apraglutide on gastric emptying of liquids in healthy subjects, as measured by the PK of acetaminophen mixed with a liquid meal.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
This is a single-center, double-blind, randomized, multiple-dose, parallel trial with a total duration of up to 50 days. The trial population will consist of healthy volunteers. Eligible subjects will be randomized to receive either subcutaneous (SC) apraglutide or matching placebo. The effect of apraglutide on gastric emptying of liquids will be assessed by the measure of PK of acetaminophen mixed with a liquid meal.
There will be two treatment periods, occurring according to the same sequence. In Period 1 acetaminophen will be given on Day 1, apraglutide/placebo will be injected on Day2. In Period 2 apraglutide/placebo will be injected on Day 9 and acetaminophen will be given on Day 10. This will allow to assess the PK of acetaminophen without the effect of apraglutide in Period 1, and to assess the PK of acetaminophen at the maximum concentration of apraglutide in Period 2.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Apraglutide SC injections
|
Drug: Apraglutide
Peptide analogue of GLP-2
Drug: Acetaminophen
Acetaminophen mixed with a liquid meal
|
| Placebo Comparator: Placebo
|
Drug: Placebo
Matching placebo to apraglutide
Drug: Acetaminophen
Acetaminophen mixed with a liquid meal
|
Outcome Measures
Primary Outcome Measures
- Maximum plasma concentration (Cmax) of acetaminophen [0-300 Minutes]
- Time at which the maximum plasma concentration is observed (tmax) of acetaminophen [0-300 Minutes]
- Area under the acetaminophen concentration-time curve: AUCinf (AUClast in case AUCinf cannot be estimated) [0-14 hours]
- Area under the acetaminophen concentration-time curve: AUC0-300min [0-300 Minutes]
- Area under the acetaminophen concentration-time curve: AUC0-60min [0-60 Minutes]
Secondary Outcome Measures
- Height [Through study completion, up to 24 days]
In cm
- Weight [Through study completion, up to 24 days]
In kg
- Physical examination [Through study completion, up to 24 days]
Clinically significant outcome (as normal or abnormal) for physical examination of eyes, neurological, gastrointestinal, respiratory, circulatory, muscular, cardiovascular, lymphatic, ears, nose, throat.
- The incidence, nature and severity of adverse events (AEs) with apraglutide [Through study completion, up to 24 days]
- Clinical chemistry [Through study completion, up to 24 days]
Clinical Chemistry panel of analytes will be examined for clinically significant changes. Clinical chemistry analytes will be listed by subject. Descriptive statistics will be used to assess any changes in clinical laboratory results during and following trial treatment administration. Values outside the reference ranges will be highlighted and clinical significance stated.
- Hematology [Through study completion, up to 24 days]
Hematology panel of analytes will be examined for clinically significant changes. Hematology analytes will be listed by subject. Descriptive statistics will be used to assess any changes in clinical laboratory results during and following trial treatment administration. Values outside the reference ranges will be highlighted and clinical significance stated.
- Hemostasis [Through study completion, up to 24 days]
Hemostasis INR will be examined for clinically significant changes
- Anti-drug antibodies (ADA) analysis [Through study completion, up to 24 days]
ADA will be will be examined for clinically significant changes
- Urine analysis [Through study completion, up to 24 days]
Urine analysis panel of analytes will be examined for clinically significant changes
- Occurrence of clinically relevant changes in vital signs [Through study completion, up to 24 days]
Systolic and diastolic blood pressure in mmHg
- Occurrence of clinically relevant changes in vital signs [Through study completion, up to 24 days]
Pulse rate in Beats per Minute
- Changes in body temperature in °C [Through study completion, up to 24 days]
- Occurrence of clinically relevant changes in electrocardiogram [Through study completion, up to 24 days]
ECG QT Interval
- Occurrence of clinically relevant changes in electrocardiogram [Through study completion, up to 24 days]
ECG PR interval
- Occurrence of clinically relevant changes in electrocardiogram [Through study completion, up to 24 days]
ECG QRS interval
- Occurrence of clinically relevant changes in electrocardiogram [Through study completion, up to 24 days]
ECG rhythm
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age between 18 and 45 years inclusive
-
Subjects who are willing and able to comply with the study procedures
-
Subjects able to understand and willing to sign the informed consent
-
Body mass index (BMI) of ≥18.0 to ≤30.0 kg/m2; and a total body weight of >50 kg (110 lb).
-
Women of childbearing potential (WOCBP) having undergone bilateral tubal occlusion or with vasectomized partner. Sterilized or infertile or postmenopausal females.
-
Male subjects with a WOCBP partner using highly effective methods of contraception and agreeing on no sperm donation during the trial and for 2 weeks after (EOT) visit.
Exclusion Criteria:
-
History of clinically significant GI, bronchopulmonary, neurological, cardiovascular, endocrine, or allergic disease
-
Known hypersensitivity to the investigational medicinal product (IMP), any of their excipients or drugs of the same class
-
If capable of reproduction, unwilling to use an effective form of contraception
-
If a WOCBP, a positive urine/blood pregnancy test
-
Breast-feeding women
-
Positive urine/blood test for alcohol and drugs of abuse
-
Use of prohibited medications or herbal remedies
-
Known presence or history of intestinal polyps
-
Known presence or history of any type of cancer
-
Pancreatic events such as acute pancreatitis, pancreatic duct stenosis, pancreas infection, and increased blood amylase and lipase (>2.0-5.0×upper limit of normal range)
-
Participation in an investigational drug or device study within 30 days prior to Screening
-
Donation of blood over 500 mL within 2 months prior to Screening
-
Use of tobacco products (i.e., smokes more than 5 cigarettes per day or equivalent)
-
Concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this trial
-
Any intercurrent clinically significant illness in the previous 28 days before Day 1 of this study
-
Positive blood screen for human immunodeficiency virus (HIV) antigen/antibody combo, hepatitis A (HAV IGM), hepatitis B surface antigen (HBsAgB), or hepatitis C virus (HCV)
-
Unwillingness or inability to comply with the study protocol for any other reason
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | ICON Clinical Research Unit | Groningen | Netherlands |
Sponsors and Collaborators
- VectivBio AG
Investigators
- Study Director: Bolognani, VectivBio AG
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TA799-020