Relative Bioavailability of a New Presentation of Apraglutide Versus the Reference Formulation

NCT06002555 | Completed Phase 1 FDA Drug

• 1 other identifier: TA799-018
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This trial compares the relative bioavailability of apraglutide in dual-chamber syringes (DCS) versus the reference formulation apraglutide in vials.

Conditions

Healthy Subjects

Keywords

Relative bioavailability; Dual-chamber syringe

Outcome Measures

Primary Outcomes (2)

• Plasma apraglutide primary PK parameter: Maximum observed plasma concentration (Cmax)

  0 to 312 hours post dose in each period

• Plasma apraglutide primary PK parameter: AUCinf or AUClast

  0 to 312 hours post dose in each period

Secondary Outcomes (13)

• Time of maximum plasma concentration (tmax)

  0 to 312 hours post dose in each period

• Terminal elimination rate constant (λz)

  0 to 312 hours post dose in each period

• Terminal half-life (t½)

  0 to 312 hours post dose in each period

• Incidence, nature and severity of adverse events (AE) with apraglutide

  Baseline to Day 79

• Clinical chemistry

  Baseline to Day 79

Study Arms (3)

Single SC dose of 5 mg from DCS

EXPERIMENTAL

Drug: Apraglutide

Two concomitant single SC doses of 2.5 mg from DCS

EXPERIMENTAL

Drug: Apraglutide

Single SC dose of 5 mg from vial

ACTIVE COMPARATOR

Drug: Apraglutide

Interventions

Apraglutide DRUG

Peptide analogue of GLP-2

Single SC dose of 5 mg from DCS; Single SC dose of 5 mg from vial; Two concomitant single SC doses of 2.5 mg from DCS

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 67 years inclusive
• Subjects 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 ≤35.0 kg/m2; and a total body weight of \>50 kg
• 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 4 weeks after (EOT) visit.

You may not qualify if:

• History of clinically significant gastrointestinal, bronchopulmonary, neurological, cardiovascular, endocrine, or allergic disease
• Known hypersensitivity to the investigational medicinal products (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 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) at Screening or on Day -1 of each period
• Participation in an investigational drug or device study within 30 days prior to screening
• Donation of blood over 500 mL within 3 months prior to screening
• Use of tobacco products (i.e., smokes more than 10 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

Study Officials

• Tomasz Masior

  VectivBio AG

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: August 21, 2023
• Study Start: May 23, 2023
• Primary Completion: September 22, 2023
• Study Completion: September 22, 2023
• Last Updated: October 26, 2024

Record last verified: 2024-01

Locations

NL (1)