A Pharmacodynamic Effect Study of AP301 in Healthy Volunteers

Healthy Subjects Clinical Trial

Official title:

A Randomized, Open-Label, Parallel Group, Phase 1 Study to Assess the Pharmacodynamic Effect of AP301 on Urinary Phosphorus Excretion in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06100627
• Other study ID #: AP301-PD-01
• Status: Completed
• Phase: Phase 1
• Start date: January 11, 2024
• Est. completion date: February 28, 2024

Study information

• Verified date: May 2024
• Source: Alebund Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, open-label, parallel-group, phase 1 study to evaluate the PD effect of AP301 capsule in healthy volunteers. The study is planned to have 4 treatment arms: Arm 1: 2.10 g/day; arm 2: 4.20 g/day; arm 3: 6.30 g/day; arm 4: 8.40 g/day.

Description:

A total of 32 participants will participate in this study and the study consists of 3 periods such as screening period, hospitalization period and follow up period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 28, 2024
• Est. primary completion date: February 8, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Important Inclusion Criteria:

• Healthy male volunteers, 18-55 years of age

• Body mass index (BMI) 18-30 kg/m2 (exclusive) at screening.

Important Exclusion Criteria:

• Serum phosphorus is below 1.00 mmol/L at screening.

• History of significant gastrointestinal disease or disorder, major gastrointestinal surgeries, or cholecystectomy

• History or symptoms of any clinically significant kidney, liver, broncho-pulmonary, gastrointestinal, neurological, psychiatric, cardiovascular, endocrine/metabolic, hematological diseases, or cancer.

• History of specific allergies or allergic conditions or known allergies to the study drug as judged by the investigator, or any confirmed significant allergic reactions (urticaria or anaphylaxis) to any drug, or multiple drug allergies (non-active hay fever is acceptable). Allowing for childhood asthma, history of mild eczema that has had no flare ups for =5 years or is fully resolved.

• Known history of allergy to common food like milk or gluten, or lactose intolerance, or special diet habit for religious/life-style reasons, which might potentially jeopardize the participant's compliance of study diet.

• Any clinically significant concomitant disease, or condition or treatment that could interfere with the conduct of the study.

• Confirmed (based on the average of 3 separate resting blood pressure measurements, after at least 5 minutes rest) systolic blood pressure (BP) greater than 150 or less than 90 mmHg, and diastolic BP greater than 90 or less than 50 mmHg at screening.

• Clinically relevant ECG abnormalities on screening ECG.

• Estimated glomerular filtration rate (eGFR) = 70 mL/min/1.73 m2.

• Positive test at screening of any of the following: Hepatitis B (HBsAg), Hepatitis C (HCV Ab) or human immunodeficiency virus (HIV-1 or HIV-2 Ab).

• Alanine aminotransferase (ALT) or aspartate transaminase (AST) > 1.5 × upper limit of normal (ULN), or any other clinically significant abnormalities in laboratory test results at screening.

• Dosed with a small-molecule or biologic investigational drug within 30 days or 90 days, respectively, or 5 half-lives (whichever is the longer) prior to first dose of this study.

• Positive urine test for drugs of abuse and/or positive alcohol test at screening.

• Any medical or social conditions that, in the view of investigator, might potentially jeopardize the participant's compliance of study.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• AP301
Orally administered

Locations

Country	Name	City	State
Australia	Nucleus Network Pty Ltd	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Alebund Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary phosphorus excretion during AP301 administration	Average daily urinary phosphorus excretion during the 3 consecutive days of AP301 treatment	From the Day 1 to Day 4 after dosing, assessed up to 3 days
Primary	Effect of AP301 on urinary phosphorus excretion	Change of average daily urinary phosphorus excretion from 3 days before treatment to 3 days during treatment.	From Day -3 to Day 4 after dosing, assessed up to 6 days
Primary	Urinary calcium excretion during AP301 administration	Average daily urinary calcium excretion during the 3 consecutive days of AP301 treatment.	From the Day 1 to Day 4 after dosing, assessed up to 3 days
Primary	Effect of AP301 on urinary calcium excretion	Change of average daily urinary calcium excretion from 3 days before treatment to 3 days during treatment.	From Day -3 to Day 4 after dosing, assessed up to 6 days
Primary	Effect of AP301 on serum phosphorus and calcium	Changes of serum phosphorus and serum calcium from baseline to end of treatment.	From Day -3 to Day 4 after dosing, assessed up to 6 days
Secondary	Incidence and severity of adverse events (AEs)	Number of participants with adverse events (AEs) and the intensity of adverse events.; Number of participants with serious adverse events (SAEs) and the intensity of adverse events.	From screening to hospitalization and follow up periods, assessed up to 43 days
Secondary	Changes in clinical laboratory values	Changes and their clinical meaningfulness in clinical laboratory values: Hematology, Biochemistry, Urinalysis	From screening to hospitalization and follow up periods, assessed up to 43 days
Secondary	Abnormal electrocardiogram (ECG) readings and their clinical meaningfulness	ECG intervals (PR [PQ], QRS, QT, QTcF) and heart rate	From screening to hospitalization and follow up periods, assessed up to 43 days
Secondary	Changes of ECG parameters and their clinical meaningfulness	ECG intervals (PR [PQ], QRS, QT, QTcF), heart rate, T-wave morphology and U-wave morphology.	From screening to hospitalization and follow up periods, assessed up to 43 days
Secondary	Abnormal vital signs and their clinical meaningfulness	Blood pressure, heart rate and body temperature	From screening to hospitalization and follow up periods, assessed up to 43 days