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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06141889




Registration number
NCT06141889
Ethics application status
Date submitted
9/11/2023
Date registered
21/11/2023

Titles & IDs
Public title
Pharmacokinetics Study of Azelaprag (BGE-105) in Older Adult Healthy Volunteers
Scientific title
A Phase 1, Single-dose, Open-label, Randomized Crossover and Multiple-dose, Open-label Study to Evaluate the Pharmacokinetics and Safety of Azelaprag in Older Adult Healthy Volunteers
Secondary ID [1] 0 0
BGE-105-004
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

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

Experimental: Single dose, 2-way crossover in Part 1, then daily dosing for 14 days in Part 2 - Study Part 1:

Participants will receive a single Dose A or B on Day 1 and then followed by a crossover to a single Dose B or A on Day 8.

Study Part 2:

Participants in Study Part 2 will receive either a single Dose C or equivalent of Dose C administered twice daily, starting on Day 1 and through Day 14


Treatment: Drugs: Azelaprag
oral, apelin receptor (APJ) agonist
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pharmacokinetics of azelaprag (BGE-105) after oral administration - AUC0-t
Timepoint [1] 0 0
Study Part 1, Predose and post dose to 144 hours after each dose received; Study Part 2, Predose and post dose to 96 hours after the final dose is received.
Primary outcome [2] 0 0
Pharmacokinetics of azelaprag (BGE-105) after multiple-dose (Part 2) - AUC0-24
Timepoint [2] 0 0
Study Part 2, Predose and post dose to 24 hours after the final dose is received.
Primary outcome [3] 0 0
Pharmacokinetics of azelaprag (BGE-105) after oral administration - AUC0-inf
Timepoint [3] 0 0
Study Part 1, Predose and post dose to 144 hours after each dose received; Study Part 2, Predose and post dose to 96 hours after the final dose is received.
Primary outcome [4] 0 0
Pharmacokinetics of azelaprag (BGE-105) after oral administration - Cmax
Timepoint [4] 0 0
Study Part 1, Predose and post dose to 144 hours after each dose received; Study Part 2, Predose and post dose to 96 hours after the final dose is received.
Primary outcome [5] 0 0
Pharmacokinetics of azelaprag (BGE-105) after oral administration - Tmax
Timepoint [5] 0 0
Study Part 1, Predose and post dose to 144 hours after each dose received; Study Part 2, Predose and post dose to 96 hours after the final dose is received.
Primary outcome [6] 0 0
Pharmacokinetics of azelaprag (BGE-105) after oral administration - T1/2
Timepoint [6] 0 0
Study Part 1, Predose and post dose to 144 hours after each dose received; Study Part 2, Predose and post dose to 96 hours after the final dose is received.
Primary outcome [7] 0 0
Oral bioavailability of azelaprag after oral administration - Total body clearance
Timepoint [7] 0 0
Study Part 1, Predose and post dose to 144 hours after each dose received; Study Part 2, Predose and post dose to 96 hours after the final dose is received.
Primary outcome [8] 0 0
Oral bioavailability of azelaprag after oral administration - Volume of distribution
Timepoint [8] 0 0
Study Part 1, Predose and post dose to 144 hours after each dose received; Study Part 2, Predose and post dose to 96 hours after the final dose is received.
Secondary outcome [1] 0 0
Safety of azelaprag after oral administration - TEAEs
Timepoint [1] 0 0
First dose to Day 21

Eligibility
Key inclusion criteria
Key

Patients who meet ALL the following inclusion criteria will be eligible to participate in the study:

1. Healthy male or female volunteers = 60 years of age
2. No history or evidence of clinically relevant medical disorders
3. Body mass index (BMI) between 18 and 40 kg/m2
4. Acceptable physical examination findings, including vital signs, and electrocardiogram (ECG)
5. Acceptable clinical laboratory values
6. Female participants of non-childbearing potential

Key
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Currently receiving treatment with another investigational drug or investigational device within 30 days (or 5 half-lives, whichever is longer)
2. Current or previous malignancy within 5 years, with the exception of non-melanoma skin cancers, cervical or breast ductal carcinoma in situ, or adenocarcinoma of the prostate
3. Positive test result for COVID (rapid test), human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C (HCV) antibodies
4. Use of any medications that might affect the metabolism of the study drug as assessed by the Investigator and Sponsor and use of any herbal supplements, vitamins, or nutritional supplements within the 14 days prior to the dose day of each dosing period or during study participation.
5. Planned elective surgery within 30 days prior to Screening, during the study period or before the participant's red blood cell (RBC) have returned to normal levels
6. Systolic blood pressure > 150 mm Hg or < 90 mm Hg or diastolic blood pressure > 95 mm Hg or < 60 mm Hg
7. Unwilling or unable to abstain from the use of nicotine or tobacco containing products (including but not limited to snuff, chewing tobacco, cigars, cigarettes, pipes, or nicotine patches) or the use of cannabis or marijuana
8. Positive urine drug screen or alcohol breath test at screening and/or known history of drug or alcohol abuse within 1 year prior to screening
9. History or evidence of any other clinically significant disorder, condition, or disease, that, in the opinion of the investigator or Sponsor medical monitor, if consulted, would pose a risk to participant safety, or interfere with the study evaluation, procedures, or completion
10. Concurrent or previous use of aspirin within 14 days and NSAIDs within 3 days before the dose day of each dosing period.

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
Crossover
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
17/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/02/2024
Sample size
Target
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
BioAge Labs, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Patrick Martin, MD
Address 0 0
BioAge Labs, Inc.
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06141889