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

NCT05168683 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-01-23

No results posted yet for this study

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.

Conditions

  • Hyperuricemia
  • Gout

Interventions

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

Sponsors & Collaborators

  • BDD Pharma Ltd

    collaborator INDUSTRY

  • Allena Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Christine Tosone · Allena Pharmaceuticals, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-11
Primary Completion
2022-02-23
Completion
2022-02-23
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05168683 on ClinicalTrials.gov