Healthy Volunteer StudyPhase 1NCT06141889
Pharmacokinetics Study of Azelaprag (BGE-105) in Older Adult Healthy Volunteers
A Phase 1 study testing Azelaprag in people with Healthy Volunteer Study, run by BioAge Labs, Inc. at 1 site in New Zealand.
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer Study
- What is being tested?
- Azelaprag
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteNew Zealand
- Study dates
- 17 Nov 2023to 2 Feb 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who meet ALL the following inclusion criteria will be eligible to participate in the study:
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Healthy Volunteer Study
- Being tested
- Azelaprag
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzelapragDrug
Also called BGE-105
oral, apelin receptor (APJ) agonist
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Azelaprag |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Number of participants with treatment emergent adverse events (TEAEs)
Measured: First dose to Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start17 Nov 2023
- Primary completion26 Jan 2024
- Study completion2 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteer StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioAge Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick Martin, MD, Study director, BioAge Labs, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141889
- Sponsor's protocol ID
- BGE-105-004
- Status last verified
- Feb 2024
- First submitted
- 9 Nov 2023
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06141889
- Acronym / sponsor ID
- BGE-105-004
- Conditions
- Healthy Volunteer Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- BioAge Labs, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- 26 Jan 2024 (actual)
- Study completion
- 2 Feb 2024 (actual)
- First posted
- 21 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single dose, 2-way crossover in Part 1, then daily dosing for 14 days in Part 2 | Experimental | Drug: AzelapragStudy 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients who meet ALL the following inclusion criteria will be eligible to participate in the study:
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzelapragAlso: BGE-105oral, apelin receptor (APJ) agonist | Drug | Single dose, 2-way crossover in Part 1, then daily dosing for 14 days in Part 2 |
Primary outcome
Pharmacokinetics of azelaprag (BGE-105) after oral administration - AUC0-t
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Oral bioavailability of azelaprag after oral administration - Volume of distribution
Time frame: 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)
1 secondary outcome
Safety of azelaprag after oral administration - TEAEs
Time frame: First dose to Day 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteer Study
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Screening Protocol
Pain
RecruitingPhase 1
A Study of [18F]LY4214835 in Healthy Volunteers and Participants With Cancer
Neoplasms, Healthy
Not yet recruiting
Testing a Smartphone App to Support a Mediterranean Diet and Strength Exercise
Treatment Adherence and Compliance, Resistance Exercise
RecruitingPhase 1
A Study to Learn How Different Forms of the Study Medicine Called Berobenatide is Taken up Into the Blood in Adults With Overweight or Obesity
Overweight and/or Obesity, Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Martin, MD study director
BioAge Labs, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Azelaprag in people with Healthy Volunteer Study, run by BioAge Labs, Inc. at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics of azelaprag (BGE-105) after oral administration - AUC0-t (time frame: 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.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.