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

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.

Study Overview

• Status: Completed
• Conditions: Hyperuricemia; Gout
• Intervention / Treatment: Drug: Each ALLN-346 treatment will be radiolabelled to contain 4 MBq 99mTc at time of dosing with light meal; Drug: Each ALLN-346 treatment will be radiolabelled to contain 4 MBq 99mTc at time of dosing in fasted/fed state

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Scotland
    • Glasgow, Scotland, United Kingdom, G4 0SF
      • BDD Pharma Ltd Bio-Imaging Centre Within Glasgow Royal Infirmary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• BMI between 18 and 30 kg/m², inclusive.
• Body weight ≥50 kg
• Voluntary written informed consent
• Good general health with no clinically significant and/or relevant abnormalities of medical history or prior to dosing evaluations, including physical examination, vital signs and ECG and screening clinical laboratory results

Exclusion Criteria:

• Current or recurrent disease that could affect the study conduct or laboratory assessments
• History of current or relevant previous non-self-limiting gastrointestinal disorders
• Currently suffering from disease known to impact gastric emptying, e.g., migraine, Type 1 or Type 2 diabetes mellitus
• Untreated hypertension or has hypertension under treatment.
• Diagnosis of an immunosuppressive illness or a condition requiring chronic immunosuppression.
• As a result of a physical examination or screening investigations, and available prior to dosing evaluations, the PMI or medically qualified designee/physician responsible considers the volunteer unfit for the study
• Any contradictions to the gamma scintigraphy procedure
• Measured body temperature >38°C at screening visit (COVID-19 risk reduction procedure)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part One; Four Study Treatments will be dosed during Part One of the study with radiolabelled ALLN-346 tablets (in 12 subjects): Treatment A ALLN-346 enteric coated (EC) fast release tablet; Treatment B ALLN-346 fast release capsule; Treatment C ALLN-346 EC slow release tablet; Treatment D ALLN-346 slow release capsule. Subjects will be dosed in a lightly fed state.	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; Other Names: Engineered urate oxidase radiolabelled
Experimental: Part Two; Following completion of Part One of the study, study treatment (one or both of those administered in Part One) and dosing requirements will be confirmed for dosing in Part Two, to be administered in fasted and/or fed states (in 12 subjects).	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; Other Names: Engineered urate oxidase radiolabelled

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scintigraphic images to detect transit time of radiolabel release	To assess the onset of disintegration/release with transit time for the radiolabelled study treatments in each ALLN-346 formulation	12 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events	Number of subjects with treatment emergent adverse events	14 Days

Collaborators and Investigators

• Sponsor: Allena Pharmaceuticals
• Collaborators: BDD Pharma Ltd
• Investigators: Study Director: Christine Tosone, Allena Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2022
• Primary Completion (Actual): February 23, 2022
• Study Completion (Actual): February 23, 2022

Study Registration Dates

• First Submitted: December 9, 2021
• First Submitted That Met QC Criteria: December 9, 2021
• First Posted (Actual): December 23, 2021

Study Record Updates

• Last Update Posted (Actual): January 23, 2023
• Last Update Submitted That Met QC Criteria: January 20, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hyperuricemia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Protective Agents; Antioxidants; Gout Suppressants; Rasburicase; Uric Acid
• Other Study ID Numbers: ALLN-346-103

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No