Evaluation of Apraglutide on Gastric Emptying

Healthy Subjects Clinical Trial

Official title:

A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single Center, Multiple-Dose, Parallel Trial Evaluating the Impact of Apraglutide on Gastric Emptying of Liquids in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05995704
• Other study ID #: TA799-020
• Status: Completed
• Phase: Phase 1
• Start date: March 2, 2023
• Est. completion date: July 24, 2023

Study information

• Verified date: January 2024
• Source: VectivBio AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 24, 2023
• Est. primary completion date: July 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• Apraglutide
Peptide analogue of GLP-2
• Placebo
Matching placebo to apraglutide
• Acetaminophen
Acetaminophen mixed with a liquid meal

Locations

Country	Name	City	State
Netherlands	ICON Clinical Research Unit	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
VectivBio AG

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma concentration (Cmax) of acetaminophen		0-300 Minutes
Primary	Time at which the maximum plasma concentration is observed (tmax) of acetaminophen		0-300 Minutes
Primary	Area under the acetaminophen concentration-time curve: AUCinf (AUClast in case AUCinf cannot be estimated)		0-14 hours
Primary	Area under the acetaminophen concentration-time curve: AUC0-300min		0-300 Minutes
Primary	Area under the acetaminophen concentration-time curve: AUC0-60min		0-60 Minutes
Secondary	Height	In cm	Through study completion, up to 24 days
Secondary	Weight	In kg	Through study completion, up to 24 days
Secondary	Physical examination	Clinically significant outcome (as normal or abnormal) for physical examination of eyes, neurological, gastrointestinal, respiratory, circulatory, muscular, cardiovascular, lymphatic, ears, nose, throat.	Through study completion, up to 24 days
Secondary	The incidence, nature and severity of adverse events (AEs) with apraglutide		Through study completion, up to 24 days
Secondary	Clinical chemistry	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.	Through study completion, up to 24 days
Secondary	Hematology	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.	Through study completion, up to 24 days
Secondary	Hemostasis	Hemostasis INR will be examined for clinically significant changes	Through study completion, up to 24 days
Secondary	Anti-drug antibodies (ADA) analysis	ADA will be will be examined for clinically significant changes	Through study completion, up to 24 days
Secondary	Urine analysis	Urine analysis panel of analytes will be examined for clinically significant changes	Through study completion, up to 24 days
Secondary	Occurrence of clinically relevant changes in vital signs	Systolic and diastolic blood pressure in mmHg	Through study completion, up to 24 days
Secondary	Occurrence of clinically relevant changes in vital signs	Pulse rate in Beats per Minute	Through study completion, up to 24 days
Secondary	Changes in body temperature in °C		Through study completion, up to 24 days
Secondary	Occurrence of clinically relevant changes in electrocardiogram	ECG QT Interval	Through study completion, up to 24 days
Secondary	Occurrence of clinically relevant changes in electrocardiogram	ECG PR interval	Through study completion, up to 24 days
Secondary	Occurrence of clinically relevant changes in electrocardiogram	ECG QRS interval	Through study completion, up to 24 days
Secondary	Occurrence of clinically relevant changes in electrocardiogram	ECG rhythm	Through study completion, up to 24 days