NCT05995704

Evaluation of Apraglutide on Gastric Emptying

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: VectivBio AG · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Apraglutide	Peptide analogue of GLP-2
DRUG	Placebo	Matching placebo to apraglutide
DRUG	Acetaminophen	Acetaminophen mixed with a liquid meal

Timeline

• Start date: 2023-03-02
• Primary completion: 2023-07-24
• Completion: 2023-07-24
• First posted: 2023-08-16
• Last updated: 2024-10-24

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated drug study