Healthy Adult MalePhase 1NCT04415645
Absorption, Metabolism, Excretion, and Mass Balance Study of [14C]-VVZ-149 in Healthy Adult Male Subjects
A Phase 1 study testing [14C]-VVZ-149 in people with Healthy Adult Male, run by Vivozon, Inc. at 1 site in United States.
Trial summary
This is an open-label, single-dose, absorption, metabolism, excretion, and mass balance study following a single IV infusion of [14C]-VVZ-149 in healthy adult male subjects. Whole blood, plasma, urine, and fecal samples will be analyzed for at least 72 hours following the start of infusion to measure total… Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Male
- What is being tested?
- [14C]-VVZ-149
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2020to 31 Mar 2020
- 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 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, adult, male, 19-55 years of age, inclusive
- Continuous non-smoker
- BMI ≥ 18.0 and ≤ 32.0 kg/m2
- Medically healthy with no clinically significant medical history or findings
- Must agree to adhere to the contraception requirements
Who cannot join
- History or presence of clinically significant medical or psychiatric condition or disease
- History or presence of alcohol or drug abuse within the past 2 years
- History, presence or evidence of cardiovascular, renal or hepatic impairment
- Less or abnormal bowel movements
- Unable to refrain from or anticipates the use of any prohibited drugs
- Recent donation of blood/plasma or significant blood loss
- Radiation exposure within 12 months
- Participation in another clinical study within 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1, Open-Label Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of a Single Intravenous Dose of [14C]-VVZ-149 in Healthy Adult Male Subjects
This is an open-label, single-dose, absorption, metabolism, excretion, and mass balance study following a single IV infusion of [14C]-VVZ-149 in healthy adult male subjects. Whole blood, plasma, urine, and fecal samples will be analyzed for at least 72 hours following the start of infusion to measure total radioactivity and plasma drug concentrations.
- Conditions
- Healthy Adult Male
- Being tested
- [14C]-VVZ-149
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-VVZ-149Drug
A single IV infusion of radio-labeled VVZ-149
| Study group | Role | What they receive |
|---|---|---|
| VVZ-149 Injections | Experimental | Not described Receives: Drug: [14C]-VVZ-149 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass balance
Sum of the percent of the total radioactivity recovered in urine and feces relative to the administered radioactivity dose
Measured: Day 15
Total radioactivity (TRA) concentration equivalents in plasma
Measured: Day 15
TRA concentration equivalents in urine
Measured: Day 15
TRA concentration equivalents in feces
Measured: Day 15
Drug concentrations in plasma
Measured: Hour 48
Secondary outcomes (1)
Treatment-emergent adverse events
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start24 Feb 2020
- Primary completion6 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult MaleStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vivozon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415645
- Sponsor's protocol ID
- VVZ149-HMB-P1-US101
- Status last verified
- May 2020
- First submitted
- 26 May 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Open-Label Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of a Single Intravenous Dose of [14C]-VVZ-149 in Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT04415645
- Acronym / sponsor ID
- VVZ149-HMB-P1-US101
- Conditions
- Healthy Adult Male
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Vivozon, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 6 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 4 Jun 2020 (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 is an open-label, single-dose, absorption, metabolism, excretion, and mass balance study following a single IV infusion of [14C]-VVZ-149 in healthy adult male subjects. Whole blood, plasma, urine, and fecal samples will be analyzed for at least 72 hours following the start of infusion to measure total radioactivity and plasma drug concentrations.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VVZ-149 Injections | Experimental | Drug: [14C]-VVZ-149 |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy, adult, male, 19-55 years of age, inclusive
- Continuous non-smoker
- BMI ≥ 18.0 and ≤ 32.0 kg/m2
- Medically healthy with no clinically significant medical history or findings
- Must agree to adhere to the contraception requirements
Key exclusion criteria (8 listed)
- History or presence of clinically significant medical or psychiatric condition or disease
- History or presence of alcohol or drug abuse within the past 2 years
- History, presence or evidence of cardiovascular, renal or hepatic impairment
- Less or abnormal bowel movements
- Unable to refrain from or anticipates the use of any prohibited drugs
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 |
|---|---|---|
| [14C]-VVZ-149A single IV infusion of radio-labeled VVZ-149 | Drug | VVZ-149 Injections |
Primary outcome
Mass balance
Time frame: Day 15
Sum of the percent of the total radioactivity recovered in urine and feces relative to the administered radioactivity dose
Total radioactivity (TRA) concentration equivalents in plasma
Time frame: Day 15
TRA concentration equivalents in urine
Time frame: Day 15
TRA concentration equivalents in feces
Time frame: Day 15
Drug concentrations in plasma
Time frame: Hour 48
1 secondary outcome
Treatment-emergent adverse events
Time frame: Day 15
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 4 Jun 2020.
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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 study testing [14C]-VVZ-149 in people with Healthy Adult Male, run by Vivozon, Inc. at 1 site in United States.
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 5 inclusion and 8 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 4 Jun 2020. 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 States. 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?
Mass balance (time frame: Day 15). The study lists 5 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 4 Jun 2020.