Back to results

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

Primary Purpose

Hyperuricemia, Gout

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

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

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

About this trial

This is an interventional other trial for Hyperuricemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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)

Sites / Locations

BDD Pharma Ltd Bio-Imaging Centre Within Glasgow Royal Infirmary

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Part One

Part Two

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of Adverse Events

Number of subjects with treatment emergent adverse events

Full Information

NCT ID

NCT05168683

First Posted

December 9, 2021

Last Updated

January 20, 2023

Sponsor

Allena Pharmaceuticals

Collaborators

BDD Pharma Ltd

1. Study Identification

Unique Protocol Identification Number

NCT05168683

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

January 11, 2022 (Actual)

Primary Completion Date

February 23, 2022 (Actual)

Study Completion Date

February 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Allena Pharmaceuticals

Collaborators

BDD Pharma Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperuricemia, Gout

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part One

Arm Type

Experimental

Arm Description

Arm Title

Part Two

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

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

Other Intervention Name(s)

Engineered urate oxidase radiolabelled

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

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

Other Intervention Name(s)

Engineered urate oxidase radiolabelled

Intervention Description

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

Primary Outcome Measure Information:

Title

Scintigraphic images to detect transit time of radiolabel release

Description

To assess the onset of disintegration/release with transit time for the radiolabelled study treatments in each ALLN-346 formulation

Time Frame

12 hours

Secondary Outcome Measure Information:

Title

Incidence of Adverse Events

Description

Number of subjects with treatment emergent adverse events

Time Frame

14 Days

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christine Tosone

Organizational Affiliation

Allena Pharmaceuticals, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

BDD Pharma Ltd Bio-Imaging Centre Within Glasgow Royal Infirmary

City

Glasgow

State/Province

Scotland

ZIP/Postal Code

G4 0SF

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs