Healthy MalesPhase 1/2NCT06834295
A Study to Evaluate Metabolism, Excretion, and Mass Balance of [14C]Vapendavir
A Phase 1/2 study testing Vapendavir in people with Healthy Males, run by Altesa Biosciences, Inc. at 1 site in United Kingdom.
Trial summary
The goal of this clinical trial is to assess how the body processes, breaks down and removes a new test medicine (vapendavir) from the body in healthy male participants.The main question it aims to answer is how the body handles the test medicine. Read more about this study
- Who is it for?
- Ages 30 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Males
- What is being tested?
- Vapendavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Mar 2025to 23 Mar 2025
- Phase
- Phase 1/2
- 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 30 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must provide written informed consent
- Must be willing and able to communicate and participate in the whole study
- Participants must demonstrate their ability to swallow 8 capsules
- Aged 30 to 65 years inclusive at the time of signing informed consent
- Must agree to adhere to the study contraception requirements
- Healthy male participants according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs, 12- lead ECG, and laboratory safety tests without any clinically significant abnormalities
- Body mass index (BMI) of 18.0 to 35.0 kg/m2 as measured at screening
- Must have regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day)
Who cannot join
- Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator
- History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
- Acute diarrhea or constipation in the 7 days before the predicted Day 1
- Participants who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening
- Clinically significant abnormal laboratory values at screening as judged by the investigator
Show all 22Show fewer
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results
- Evidence of renal impairment at screening
- Participants who have received any IMP in a clinical research study within the 90 days prior to Day 1, or less than 5 elimination half-lives prior to Day 1, whichever is longer
- Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study
- Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood
- Participants who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 3 g of paracetamol per day) in the 14 days before dosing
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption >21 units per week (1 unit = 1⁄2 pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 = 125 mL glass of wine, depending on type)
- A confirmed positive alcohol breath test
- Current smokers and those who have smoked within the last 12 months
- Current users of e-cigarettes or nicotine replacement products and those who have used these products within the last 12 months
- A confirmed breath carbon monoxide reading of greater than 10 ppm
- Confirmed positive drugs of abuse test result
- Male participants with pregnant or lactating partners
- Participants who are, or are immediate family members of, a study site or sponsor or employee
- Failure to satisfy the investigator of fitness to participate for any other reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single-dose Study To Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]Vapendavir in Healthy Male Subjects
The goal of this clinical trial is to assess how the body processes, breaks down and removes a new test medicine (vapendavir) from the body in healthy male participants.The main question it aims to answer is how the body handles the test medicine. In order to do that, the test medicine will be radiolabeled to track the test medicine in the body.
Healthy male participants who meet entry criteria will be admitted to the clinic for a duration of approximately 9 days (Day -1 to Day 8). Participants will be admitted in the evening on the day before dosing (Day -1). Participants will take a single oral dose of radiolabeled vapendavir on Day 1 and have samples collected and safety tests completed during various times throughout their stay in the the clinic. The safety tests will provide additional information on the safety and tolerability of the test medicine.
- Conditions
- Healthy Males
- Being tested
- Vapendavir
- Keywords
- ADME Study in Healthy Males
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VapendavirDrug
Single oral dose of [14C]vapendavir
| Study group | Role | What they receive |
|---|---|---|
| Open-label, non-randomized, single-dose of [14C]Vapendavir | Experimental | Single oral dose of [14C]Vapendavir Receives: Drug: Vapendavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the mass balance recovery after a single oral dose of carbon-14 ([14C])vapendavir.
Mass balance recovery of total radioactivity in all excreta (urine and feces): CumAe and Cum%Ae.
Measured: From enrollment until the mass balance criteria have been met (~ 8 days).
Secondary outcomes (17)
To determine the routes and rates of elimination of [14C]vapendavir.
Determination of routes and rates of elimination of [14C]vapendavir by Ae, %Ae, CumAe and Cum%Ae by interval.
Measured: From enrollment until the mass balance criteria have been met (~ 8 days).
To perform metabolite profiling and structural identification from plasma, urine and fecal samples.
Identification of the chemical structure of each metabolite accounting for greater than or equal to 10% of circulating radioactivity in plasma ("AUC pool"), and accounting for greater than or equal to 10% of the dose in urine (from urine pools) and feces (fecal homogenate pools) will be performed.
Measured: From enrollment until the mass balance criteria have been met (~ 8 days).
To identify the chemical structure of each metabolite accounting for more than 10% of circulating total radioactivity or accounting for 10% or more of the dose in excreta.
Identification of the chemical structure of each metabolite accounting for more than 10% by AUC of circulating total radioactivity or accounting for 10% or more of the dose in excreta.
Measured: From enrollment until the mass balance criteria have been met (~ 8 days).
To evaluate the extent of distribution of total radioactivity into blood cells.
Evaluation of whole blood: plasma concentration ratios for total radioactivity.
Measured: From enrollment until the mass balance criteria have been met (~ 8 days).
To further explore the oral pharmacokinetic (PK) of vapendavir. To characterise the PK of vapendavir and total radioactivity in plasma following a single oral dose of [14C]vapendavir.
Time prior to the first measurable concentration (Tlag)
Measured: From enrollment until the mass balance criteria have been met (~ 8 days).
To provide additional safety and tolerability information for vapendavir by assessing: incidence of adverse events (AEs), new physical examination findings and change from baseline for vital signs, electrocardiograms (ECGs), and laboratory safety tests.
Descriptive summaries for all safety data (AEs, vital signs, ECGs and safety laboratory assessments) will be provided.
Measured: From enrollment until the mass balance criteria have been met (~ 8 days).
To further explore the oral pharmacokinetic (PK) of vapendavir. To characterise the PK of vapendavir and total radioactivity in plasma following a single oral dose of [14C]vapendavir.
Time of maximum observed concentration (Tmax)
Measured: From enrollment until the mass balance criteria have been met (~ 8 days)
To further explore the oral pharmacokinetic (PK) of vapendavir. To characterise the PK of vapendavir and total radioactivity in plasma following a single oral dose of [14C]vapendavir.
Maximum observed concentration (Cmax)
Measured: From enrollment until the mass balance criteria have been met (~ 8 days)
To further explore the oral pharmacokinetic (PK) of vapendavir. To characterise the PK of vapendavir and total radioactivity in plasma following a single oral dose of [14C]vapendavir.
Area under the curve from time 0 to the time of last measurable concentration (AUC (0-last))
Measured: From enrollment until the mass balance criteria have been met (~ 8 days)
To further explore the oral pharmacokinetic (PK) of vapendavir. To characterise the PK of vapendavir and total radioactivity in plasma following a single oral dose of [14C]vapendavir.
Area under the curve from time 0 extrapolated to infinity (AUC (0-inf))
Measured: From enrollment until the mass balance criteria have been met (~ 8 days)
To further explore the oral pharmacokinetic (PK) of vapendavir. To characterise the PK of vapendavir and total radioactivity in plasma following a single oral dose of [14C]vapendavir.
Terminal elimination half-life (T1/2)
Measured: From enrollment until the mass balance criteria have been met (~ 8 days)
To further explore the oral pharmacokinetic (PK) of vapendavir. To characterise the PK of vapendavir and total radioactivity in plasma following a single oral dose of [14C]vapendavir.
First order rate constant associated with the terminal (log-linear) portion of the curve (Ke)
Measured: From enrollment until the mass balance criteria have been met (~ 8 days)
To further explore the oral pharmacokinetic (PK) of vapendavir. To characterise the PK of vapendavir and total radioactivity in plasma following a single oral dose of [14C]vapendavir.
Total body clearance calculated after a single extravascular administration where F (fraction of dose bioavailable) is unknown (CL/F)
Measured: From enrollment until the mass balance criteria have been met (~ 8 days)
To further explore the oral pharmacokinetic (PK) of vapendavir. To characterise the PK of vapendavir and total radioactivity in plasma following a single oral dose of [14C]vapendavir.
Area under the curve from time of the last measurable concentration to infinity as a percentage of the area under the cure extrapolated to infinity (AUCextrap)
Measured: From enrollment until the mass balance criteria have been met (~ 8 days)
To further explore the oral pharmacokinetic (PK) of vapendavir. To characterise the PK of vapendavir and total radioactivity in plasma following a single oral dose of [14C]vapendavir.
Mean residence time from time 0 to time of the last measurable concentration (MRT(0-last))
Measured: From enrollment until the mass balance criteria have been met (~ 8 days)
To further explore the oral pharmacokinetic (PK) of vapendavir. To characterise the PK of vapendavir and total radioactivity in plasma following a single oral dose of [14C]vapendavir.
Mean residence time from time 0 to extrapolated to infinity (MRT(0-inf))
Measured: From enrollment until the mass balance criteria have been met (~ 8 days)
To further explore the oral pharmacokinetic (PK) of vapendavir. To characterise the PK of vapendavir and total radioactivity in plasma following a single oral dose of [14C]vapendavir.
Apparent volume of distribution based on the terminal phase calculated using AUC(0-inf) after a single extravascular administration where F (fraction of dose bioavailable) is unknown (Vd/F).
Measured: From enrollment until the mass balance criteria have been met (~ 8 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start12 Mar 2025
- Primary completion23 Mar 2025
- Study completion23 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy MalesStudies 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 1/2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altesa Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834295
- Sponsor's protocol ID
- ALT VPV-102
- Status last verified
- May 2025
- First submitted
- 11 Feb 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-dose Study To Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]Vapendavir in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT06834295
- Acronym / sponsor ID
- ALT VPV-102
- Conditions
- Healthy Males
- Keywords
- ADME Study in Healthy Males
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Altesa Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- 23 Mar 2025 (actual)
- Study completion
- 23 Mar 2025 (actual)
- First posted
- 19 Feb 2025 (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.
The goal of this clinical trial is to assess how the body processes, breaks down and removes a new test medicine (vapendavir) from the body in healthy male participants.The main question it aims to answer is how the body handles the test medicine. In order to do that, the test medicine will be radiolabeled to track the test medicine in the body.
Healthy male participants who meet entry criteria will be admitted to the clinic for a duration of approximately 9 days (Day -1 to Day 8). Participants will be admitted in the evening on the day before dosing (Day -1). Participants will take a single oral dose of radiolabeled vapendavir on Day 1 and have samples collected and safety tests completed during various times throughout their stay in the the clinic. The safety tests will provide additional information on the safety and tolerability of the test medicine.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-label, non-randomized, single-dose of [14C]Vapendavir | Experimental | Drug: VapendavirSingle oral dose of [14C]Vapendavir |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Must provide written informed consent
- Must be willing and able to communicate and participate in the whole study
- Participants must demonstrate their ability to swallow 8 capsules
- Aged 30 to 65 years inclusive at the time of signing informed consent
- Must agree to adhere to the study contraception requirements
Key exclusion criteria (22 listed)
- Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator
- History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
- Acute diarrhea or constipation in the 7 days before the predicted Day 1
- Participants who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening
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 |
|---|---|---|
| VapendavirSingle oral dose of [14C]vapendavir | Drug | Open-label, non-randomized, single-dose of [14C]Vapendavir |
Primary outcome
To determine the mass balance recovery after a single oral dose of carbon-14 ([14C])vapendavir.
Time frame: From enrollment until the mass balance criteria have been met (~ 8 days).
Mass balance recovery of total radioactivity in all excreta (urine and feces): CumAe and Cum%Ae.
17 secondary outcomes
To determine the routes and rates of elimination of [14C]vapendavir.
Time frame: From enrollment until the mass balance criteria have been met (~ 8 days).
To perform metabolite profiling and structural identification from plasma, urine and fecal samples.
Time frame: From enrollment until the mass balance criteria have been met (~ 8 days).
To identify the chemical structure of each metabolite accounting for more than 10% of circulating total radioactivity or accounting for 10% or more of the dose in excreta.
Time frame: From enrollment until the mass balance criteria have been met (~ 8 days).
To evaluate the extent of distribution of total radioactivity into blood cells.
Time frame: From enrollment until the mass balance criteria have been met (~ 8 days).
To further explore the oral pharmacokinetic (PK) of vapendavir. To characterise the PK of vapendavir and total radioactivity in plasma following a single oral dose of [14C]vapendavir.
Time frame: From enrollment until the mass balance criteria have been met (~ 8 days).
To provide additional safety and tolerability information for vapendavir by assessing: incidence of adverse events (AEs), new physical examination findings and change from baseline for vital signs, electrocardiograms (ECGs), and laboratory safety tests.
Time frame: From enrollment until the mass balance criteria have been met (~ 8 days).
To further explore the oral pharmacokinetic (PK) of vapendavir. To characterise the PK of vapendavir and total radioactivity in plasma following a single oral dose of [14C]vapendavir.
Time frame: From enrollment until the mass balance criteria have been met (~ 8 days)
To further explore the oral pharmacokinetic (PK) of vapendavir. To characterise the PK of vapendavir and total radioactivity in plasma following a single oral dose of [14C]vapendavir.
Time frame: From enrollment until the mass balance criteria have been met (~ 8 days)
To further explore the oral pharmacokinetic (PK) of vapendavir. To characterise the PK of vapendavir and total radioactivity in plasma following a single oral dose of [14C]vapendavir.
Time frame: From enrollment until the mass balance criteria have been met (~ 8 days)
To further explore the oral pharmacokinetic (PK) of vapendavir. To characterise the PK of vapendavir and total radioactivity in plasma following a single oral dose of [14C]vapendavir.
Time frame: From enrollment until the mass balance criteria have been met (~ 8 days)
To further explore the oral pharmacokinetic (PK) of vapendavir. To characterise the PK of vapendavir and total radioactivity in plasma following a single oral dose of [14C]vapendavir.
Time frame: From enrollment until the mass balance criteria have been met (~ 8 days)
To further explore the oral pharmacokinetic (PK) of vapendavir. To characterise the PK of vapendavir and total radioactivity in plasma following a single oral dose of [14C]vapendavir.
Time frame: From enrollment until the mass balance criteria have been met (~ 8 days)
To further explore the oral pharmacokinetic (PK) of vapendavir. To characterise the PK of vapendavir and total radioactivity in plasma following a single oral dose of [14C]vapendavir.
Time frame: From enrollment until the mass balance criteria have been met (~ 8 days)
To further explore the oral pharmacokinetic (PK) of vapendavir. To characterise the PK of vapendavir and total radioactivity in plasma following a single oral dose of [14C]vapendavir.
Time frame: From enrollment until the mass balance criteria have been met (~ 8 days)
To further explore the oral pharmacokinetic (PK) of vapendavir. To characterise the PK of vapendavir and total radioactivity in plasma following a single oral dose of [14C]vapendavir.
Time frame: From enrollment until the mass balance criteria have been met (~ 8 days)
To further explore the oral pharmacokinetic (PK) of vapendavir. To characterise the PK of vapendavir and total radioactivity in plasma following a single oral dose of [14C]vapendavir.
Time frame: From enrollment until the mass balance criteria have been met (~ 8 days)
To further explore the oral pharmacokinetic (PK) of vapendavir. To characterise the PK of vapendavir and total radioactivity in plasma following a single oral dose of [14C]vapendavir.
Time frame: From enrollment until the mass balance criteria have been met (~ 8 days).
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 28 May 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Healthy Males
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
Not yet recruitingPhase 1
A Clinical Trial of MK-6916 in Participants With Moderate and Severe Kidney Disease Compared to Healthy Controls (MK-6916-013)
Healthy, Renal Impairment
RecruitingPhase 1
A Study to Investigate the Pharmacokinetics and Safety of PKN605 in Participants With Moderate and Severe Renal Impairment Compared to Matched Control Subjects With Normal Renal Function
Participants With Moderate and Severe Renal Impairment and Healthy Participants
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingPhase 1
Evaluate the Effect of Vimseltinib on P-glycoprotein (P-gp) Inhibition in Healthy Male Participants
Healthy Male 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vapendavir in people with Healthy Males, run by Altesa Biosciences, Inc. at 1 site in United Kingdom.
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 8 inclusion and 22 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 28 May 2025. 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 United Kingdom. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To determine the mass balance recovery after a single oral dose of carbon-14 ([14C])vapendavir. (time frame: From enrollment until the mass balance criteria have been met (~ 8 days).). 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 28 May 2025.