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

NCT06141889 | Completed Phase 1

• 1 other identifier: BGE-105-004
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteer Study

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• Safety of azelaprag after oral administration - TEAEs

  First dose to Day 21

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

Azelaprag DRUG

oral, apelin receptor (APJ) agonist

Also known as: BGE-105

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

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Currently receiving treatment with another investigational drug or investigational device within 30 days (or 5 half-lives, whichever is longer)
• 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
• Positive test result for COVID (rapid test), human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C (HCV) antibodies
• 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.
• 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
• Systolic blood pressure \> 150 mm Hg or \< 90 mm Hg or diastolic blood pressure \> 95 mm Hg or \< 60 mm Hg
• 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
• 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
• 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
• Concurrent or previous use of aspirin within 14 days and NSAIDs within 3 days before the dose day of each dosing period.

Sponsors & Collaborators

• BioAge Labs, Inc.: lead

Study Sites (1)

New Zealand Clinical Research

Auckland, New Zealand

Location

Study Officials

• Patrick Martin, MD

  BioAge Labs, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 21, 2023
• Study Start: November 17, 2023
• Primary Completion: January 26, 2024
• Study Completion: February 2, 2024
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)