Healthy Volunteer Study
Conditions
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.
Interventions
DRUGAzelaprag
oral, apelin receptor (APJ) agonist
Sponsors
BioAge Labs, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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) |
| 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 - 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) |
| 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) |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of azelaprag after oral administration - TEAEs | First dose to Day 21 | Number of participants with treatment emergent adverse events (TEAEs) |
Countries
New Zealand
Outcome results
None listed