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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer Study
• Intervention / Treatment: Drug: Azelaprag

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• New Zealand
  • Auckland, New Zealand
    • New Zealand Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: Azelaprag; oral, apelin receptor (APJ) agonist; Other Names: BGE-105

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of azelaprag after oral administration - TEAEs	Number of participants with treatment emergent adverse events (TEAEs)	First dose to Day 21

Collaborators and Investigators

• Sponsor: BioAge Labs, Inc.
• Investigators: Study Director: Patrick Martin, MD, BioAge Labs, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2023
• Primary Completion (Actual): January 26, 2024
• Study Completion (Actual): February 2, 2024

Study Registration Dates

• First Submitted: November 9, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Actual): November 21, 2023

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: BGE-105-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No