Evaluation of Apraglutide on Gastric Emptying

NCT05995704 | Completed Phase 1 FDA Drug

• 1 other identifier: TA799-020
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Keywords

Gastric emptying; Pharmacokinetics of acetaminophen

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (16)

• Height

  Through study completion, up to 24 days

• Weight

  Through study completion, up to 24 days

• Physical examination

  Through study completion, up to 24 days

• 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

Study Arms (2)

Apraglutide SC injections

EXPERIMENTAL

Drug: Apraglutide; Drug: Acetaminophen

Placebo

PLACEBO COMPARATOR

Drug: Placebo; Drug: Acetaminophen

Interventions

Apraglutide DRUG

Peptide analogue of GLP-2

Apraglutide SC injections

Placebo DRUG

Matching placebo to apraglutide

Placebo

Acetaminophen DRUG

Acetaminophen mixed with a liquid meal

Apraglutide SC injections; Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VectivBio AG: lead

Study Sites (1)

ICON Clinical Research Unit

Groningen, Netherlands

Location

MeSH Terms

Interventions

apraglutide; Acetaminophen

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Tomasz Masior

  VectivBio AG

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The pharmacist and designated staff will be unblinded.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: August 16, 2023
• Study Start: March 2, 2023
• Primary Completion: July 24, 2023
• Study Completion: July 24, 2023
• Last Updated: October 24, 2024

Record last verified: 2024-01

Locations

NL (1)