NCT05168683

Scintigraphy Study in Healthy Volunteers to Characterize the Performance of ALLN-346 Tablets

A Phase 1, Single Centre, Two-Part, Open Label, Crossover Study in Healthy Volunteers Using Scintigraphy to Characterize the In Vivo Performance of ALLN-346 Enteric Coated Tablets

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Allena Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to understand the gastrointestinal transit time and disintegration behavior of the formulations in vivo in normal healthy volunteers when ALLN-346 formulations are given with light meal or in fasted or other fed states.

Detailed description

This study includes two parts. Part One will evaluate two ALLN-346 formulations, a fast release and a slower sustained release. Subjects will receive a single tablet of each formulation and a capsule of each formulation at separate assessment visits. Subjects will attend a maximum of 4 assessment visits. The primary purpose of this part of the study is to understand the gastrointestinal transit time and disintegration behaviour of the formulations in vivo in normal healthy volunteers when ALLN-346 formulations are given with light meal. Part Two will involve a second cohort of subjects and will comprise further scintigraphic studies on one or both formulation(s) from Part One in fasted and/or fed states. Subjects will attend a maximum of 4 assessment visits, the number of treatment arms will be decided following completion of Part One.

Conditions

• Hyperuricemia
• Gout

Interventions

Type	Name	Description
DRUG	Each ALLN-346 treatment will be radiolabelled to contain 4 MBq 99mTc at time of dosing with light meal	Dosing or radiolabelled ALLN-346 fast or slow release tablets or capsules. Scintigraphic images will be taken
DRUG	Each ALLN-346 treatment will be radiolabelled to contain 4 MBq 99mTc at time of dosing in fasted/fed state	Selected dosing of Part One treatments in fasted and/or fed states

Timeline

• Start date: 2022-01-11
• Primary completion: 2022-02-23
• Completion: 2022-02-23
• First posted: 2021-12-23
• Last updated: 2023-01-23

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study