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

Gout Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05168683
• Other study ID #: ALLN-346-103
• Status: Completed
• Phase: Phase 1
• Start date: January 11, 2022
• Est. completion date: February 23, 2022

Study information

• Verified date: January 2023
• Source: Allena Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 23, 2022
• Est. primary completion date: February 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Gout
• Hyperuricemia

Intervention

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
• 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

Locations

Country	Name	City	State
United Kingdom	BDD Pharma Ltd Bio-Imaging Centre Within Glasgow Royal Infirmary	Glasgow	Scotland

Sponsors (2)

Lead Sponsor	Collaborator
Allena Pharmaceuticals	BDD Pharma Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of Adverse Events	Number of subjects with treatment emergent adverse events	14 Days