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

• Status: Recruiting
• Trial end date: 2022-04-30
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Allena Pharmaceuticals
• Collaborator: BDD Pharma Ltd
• Treatments: Rasburicase; Uric Acid

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)