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

NCT05168683 | Completed Phase 1 FDA Drug

• 1 other identifier: ALLN-346-103
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of Adverse Events

  14 Days

Study Arms (2)

Part One

EXPERIMENTAL

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

Part Two

EXPERIMENTAL

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

Interventions

Each ALLN-346 treatment will be radiolabelled to contain 4 MBq 99mTc at time of dosing with light meal DRUG

Dosing or radiolabelled ALLN-346 fast or slow release tablets or capsules. Scintigraphic images will be taken

Also known as: Engineered urate oxidase radiolabelled

Part One

Each ALLN-346 treatment will be radiolabelled to contain 4 MBq 99mTc at time of dosing in fasted/fed state DRUG

Selected dosing of Part One treatments in fasted and/or fed states

Also known as: Engineered urate oxidase radiolabelled

Part Two

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Allena Pharmaceuticals: lead
• BDD Pharma Ltd: collaborator

Study Sites (1)

BDD Pharma Ltd Bio-Imaging Centre Within Glasgow Royal Infirmary

Glasgow, Scotland, G4 0SF, United Kingdom

Location

MeSH Terms

Conditions

Hyperuricemia; Gout

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Christine Tosone

  Allena Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

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

Model Details: Subjects in each study Part participate in all treatment arms of that Part.

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: December 23, 2021
• Study Start: January 11, 2022
• Primary Completion: February 23, 2022
• Study Completion: February 23, 2022
• Last Updated: January 23, 2023

Record last verified: 2023-01

Locations

GB (1)