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

Phase 1

Completed

• Conditions: Healthy Volunteer Study
• Interventions: Drug: Azelaprag

• Registration Number: NCT06141889
• Lead Sponsor: BioAge Labs, Inc.

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.

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 Timeline

• Study First Submitted: 2023-11-09
• Study First Submitted QC: 2023-11-15
• Study Start: 2023-11-17
• Study First Posted: 2023-11-21
• Primary Completion: 2024-01-26
• Status Verified: 2024-02
• Study Completion: 2024-02-02
• Last Update Submitted: 2024-02-21
• Last Update Posted: 2024-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Oral bioavailability of azelaprag after oral administration - Total body clearance	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.	Assessment of PK parameter, Total body clearance (CL)
Pharmacokinetics of azelaprag (BGE-105) after oral administration - 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.	Assessment of PK parameter, area under the curve (AUC) from time 0 to time of the last observed serum concentration (AUC0-t)
Oral bioavailability of azelaprag after oral administration - Volume of distribution	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.	Assessment of PK parameter, volume of distribution (Vz)
Pharmacokinetics of azelaprag (BGE-105) after multiple-dose (Part 2) - AUC0-24	Study Part 2, Predose and post dose to 24 hours after the final dose is received.	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)
Pharmacokinetics of azelaprag (BGE-105) after oral administration - 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.	Assessment of PK parameter, time to reach Cmax (Tmax)
Pharmacokinetics of azelaprag (BGE-105) after oral administration - 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.	Assessment of PK parameter, terminal elimination half-life (T1/2)
Pharmacokinetics of azelaprag (BGE-105) after oral administration - 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.	Assessment of PK parameter, UAC from time 0 to infinity (AUC0-inf)
Pharmacokinetics of azelaprag (BGE-105) after oral administration - 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.	Assessment of PK parameter, maximum observed serum concentration (Cmax)

Secondary Outcome Measures

Name	Time	Method
Safety of azelaprag after oral administration - TEAEs	First dose to Day 21	Number of participants with treatment emergent adverse events (TEAEs)

Trial Locations

Locations (1)

New Zealand Clinical Research; 🇳🇿 Auckland, New Zealand