Evaluation of Apraglutide on Gastric Emptying

VectivBio

Status and phase

Completed

Phase 1

Conditions

Healthy Subjects

Treatments

Drug: Placebo

Drug: Acetaminophen

Drug: Apraglutide

Study type

Interventional

Funder types

Industry

Identifiers

NCT05995704

TA799-020

Details and patient eligibility

About

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.

Full 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.

Enrollment

42 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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