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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06100627




Registration number
NCT06100627
Ethics application status
Date submitted
17/10/2023
Date registered
25/10/2023
Date last updated
10/05/2024

Titles & IDs
Public title
A Pharmacodynamic Effect Study of AP301 in Healthy Volunteers
Scientific title
A Randomized, Open-Label, Parallel Group, Phase 1 Study to Assess the Pharmacodynamic Effect of AP301 on Urinary Phosphorus Excretion in Healthy Volunteers
Secondary ID [1] 0 0
AP301-PD-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Subjects 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AP301

Experimental: 2.10 g/day of AP301 -

Experimental: 4.20 g/day of AP301 -

Experimental: 6.30 g/day of AP301 -

Experimental: 8.40 g.day of AP301 -


Treatment: Drugs: AP301
Orally administered
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Urinary phosphorus excretion during AP301 administration
Timepoint [1] 0 0
From the Day 1 to Day 4 after dosing, assessed up to 3 days
Primary outcome [2] 0 0
Effect of AP301 on urinary phosphorus excretion
Timepoint [2] 0 0
From Day -3 to Day 4 after dosing, assessed up to 6 days
Primary outcome [3] 0 0
Urinary calcium excretion during AP301 administration
Timepoint [3] 0 0
From the Day 1 to Day 4 after dosing, assessed up to 3 days
Primary outcome [4] 0 0
Effect of AP301 on urinary calcium excretion
Timepoint [4] 0 0
From Day -3 to Day 4 after dosing, assessed up to 6 days
Primary outcome [5] 0 0
Effect of AP301 on serum phosphorus and calcium
Timepoint [5] 0 0
From Day -3 to Day 4 after dosing, assessed up to 6 days
Secondary outcome [1] 0 0
Incidence and severity of adverse events (AEs)
Timepoint [1] 0 0
From screening to hospitalization and follow up periods, assessed up to 43 days
Secondary outcome [2] 0 0
Changes in clinical laboratory values
Timepoint [2] 0 0
From screening to hospitalization and follow up periods, assessed up to 43 days
Secondary outcome [3] 0 0
Abnormal electrocardiogram (ECG) readings and their clinical meaningfulness
Timepoint [3] 0 0
From screening to hospitalization and follow up periods, assessed up to 43 days
Secondary outcome [4] 0 0
Changes of ECG parameters and their clinical meaningfulness
Timepoint [4] 0 0
From screening to hospitalization and follow up periods, assessed up to 43 days
Secondary outcome [5] 0 0
Abnormal vital signs and their clinical meaningfulness
Timepoint [5] 0 0
From screening to hospitalization and follow up periods, assessed up to 43 days

Eligibility
Key inclusion criteria
Important

- Healthy male volunteers, 18-55 years of age

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

Important
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/01/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/02/2024
Sample size
Target
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Alebund Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06100627
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sam Francis, Doctor
Address 0 0
Nucleus Network
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries