Gout, Hyperuricemia
Conditions
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.
Interventions
DRUGEach 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
DRUGEach 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
BDD Pharma Ltd
Allena Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
Subjects in each study Part participate in all treatment arms of that Part.
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scintigraphic images to detect transit time of radiolabel release | 12 hours | To assess the onset of disintegration/release with transit time for the radiolabelled study treatments in each ALLN-346 formulation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events | 14 Days | Number of subjects with treatment emergent adverse events |
Countries
United Kingdom
Outcome results
None listed