Pharmacokinetics Study of Azelaprag (BGE-105) in Older Adult Healthy Volunteers

Healthy Volunteer Study Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06141889
• Other study ID #: BGE-105-004
• Status: Completed
• Phase: Phase 1
• Start date: November 17, 2023
• Est. completion date: February 2, 2024

Study information

• Verified date: February 2024
• Source: BioAge Labs, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a single-dose, open-label, randomized crossover and multiple-dose, open-label study to evaluate the PK of azelaprag in older adult healthy volunteers.

Description:

This study is a single-dose, open-label, randomized crossover and multiple-dose, open-label study to evaluate the PK of azelaprag in older adult healthy volunteers. The study will enroll approximately 16 participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 2, 2024
• Est. primary completion date: January 26, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Key Inclusion Criteria:

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 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.

Related Conditions & MeSH terms

• Healthy Volunteer Study

Intervention

Drug:
• Azelaprag
oral, apelin receptor (APJ) agonist

Locations

Country	Name	City	State
New Zealand	New Zealand Clinical Research	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
BioAge Labs, Inc.

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of azelaprag (BGE-105) after oral administration - AUC0-t	Assessment of PK parameter, area under the curve (AUC) from time 0 to time of the last observed serum concentration (AUC0-t)	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	Pharmacokinetics of azelaprag (BGE-105) after multiple-dose (Part 2) - AUC0-24	Assessment of PK parameter, area under the curve (AUC) over the dosing interval from time 0 to 24 hours following the final dose (AUC0-24)	Study Part 2, Predose and post dose to 24 hours after the final dose is received.
Primary	Pharmacokinetics of azelaprag (BGE-105) after oral administration - AUC0-inf	Assessment of PK parameter, UAC from time 0 to infinity (AUC0-inf)	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	Pharmacokinetics of azelaprag (BGE-105) after oral administration - Cmax	Assessment of PK parameter, maximum observed serum concentration (Cmax)	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	Pharmacokinetics of azelaprag (BGE-105) after oral administration - Tmax	Assessment of PK parameter, time to reach Cmax (Tmax)	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	Pharmacokinetics of azelaprag (BGE-105) after oral administration - T1/2	Assessment of PK parameter, terminal elimination half-life (T1/2)	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	Oral bioavailability of azelaprag after oral administration - Total body clearance	Assessment of PK parameter, Total body clearance (CL)	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	Oral bioavailability of azelaprag after oral administration - Volume of distribution	Assessment of PK parameter, volume of distribution (Vz)	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	Safety of azelaprag after oral administration - TEAEs	Number of participants with treatment emergent adverse events (TEAEs)	First dose to Day 21