Healthy VolunteersPhase 1NCT03177278
A Study to Assess the Metabolism, Excretion, and Mass Balance of Radio-Labeled Plazomicin
A Phase 1 study testing [14C]-plazomicin in people with Healthy Volunteers, run by Achaogen, Inc. at 1 site in United States.
Trial summary
This is a single-center, open label, non-randomized metabolism, excretion, and mass balance study of a single IV infusion of [14C]-plazomicin in healthy, adult male subjects. 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 Volunteers
- What is being tested?
- [14C]-plazomicin
- 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
- 16 Jun 2017to 10 Jul 2017
- 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
- Medically healthy, with no clinically significant medical history, physical examination findings, vital signs or ECG findings
Who cannot join
- Use of tobacco- or nicotine-containing products
- Has received radio-labeled substances or has been exposed to radiation sources within 12 months of dosing or is likely to receive radiation exposure or radioisotopes within 12 months of dosing such that participation in this study would increase their total exposure beyond the recommended levels considered safe
- History of hearing loss or a family history of hearing loss, or a prior diagnosis of sensorineural hearing loss or Ménière's disease
- History in the past 90 days of prior trauma to the outer or internal structures of the ear or tinnitus
- History or family history of vestibular disorder, chronic vertigo (sensation of spinning), chronic dizziness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label Study to Assess the Metabolism, Excretion, and Mass Balance of [14C]-Plazomicin Following a Single IV Infusion in Healthy Adult Male Subjects
This is a single-center, open label, non-randomized metabolism, excretion, and mass balance study of a single IV infusion of [14C]-plazomicin in healthy, adult male subjects.
- Conditions
- Healthy Volunteers
- Being tested
- [14C]-plazomicin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-plazomicinDrug
single intravenous dose
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: [14C]-plazomicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sum of percent of total radioactivity recovered in urine and feces relative to the administered radioactive dose minus any radioactivity lost due to emesis
Measured: 15 days
Total radioactivity concentration equivalents in plasma and blood
Measured: 15 days
Plazomicin concentrations in plasma and urine
Measured: 15 days
Secondary outcomes (4)
Incidence and severity of adverse events
Measured: 21 days
Change from baseline in vital signs post dose (temperature, pulse, respiration, blood pressure)
Measured: 1 day
Absolute values of and change from baseline in clinical laboratory values (hematology, serum chemistry, urine analysis)
Measured: 4 days
Physical examination
Measured: Screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start16 Jun 2017
- Primary completion10 Jul 2017
- Study completion10 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Achaogen, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Responsible party
- Sponsor
- Investigators
- Shyeilla Dhuria, Study director, Achaogen, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177278
- Sponsor's protocol ID
- ACHN-490-010
- Status last verified
- Jul 2017
- First submitted
- 1 Jun 2017
- Last updated
- 12 Jul 2017
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study to Assess the Metabolism, Excretion, and Mass Balance of [14C]-Plazomicin Following a Single IV Infusion in Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT03177278
- Acronym / sponsor ID
- ACHN-490-010
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Achaogen, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- 16 Jun 2017 (actual)
- Primary completion
- 10 Jul 2017 (actual)
- Study completion
- 10 Jul 2017 (actual)
- First posted
- 6 Jun 2017 (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 a single-center, open label, non-randomized metabolism, excretion, and mass balance study of a single IV infusion of [14C]-plazomicin in healthy, adult male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: [14C]-plazomicin |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Medically healthy, with no clinically significant medical history, physical examination findings, vital signs or ECG findings
Key exclusion criteria (5 listed)
- Use of tobacco- or nicotine-containing products
- Has received radio-labeled substances or has been exposed to radiation sources within 12 months of dosing or is likely to receive radiation exposure or radioisotopes within 12 months of dosing such that participation in this study would increase their total exposure beyond the recommended levels considered safe
- History of hearing loss or a family history of hearing loss, or a prior diagnosis of sensorineural hearing loss or Ménière's disease
- History in the past 90 days of prior trauma to the outer or internal structures of the ear or tinnitus
- History or family history of vestibular disorder, chronic vertigo (sensation of spinning), chronic dizziness
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]-plazomicinsingle intravenous dose | Drug | Arm 1 |
Primary outcome
Sum of percent of total radioactivity recovered in urine and feces relative to the administered radioactive dose minus any radioactivity lost due to emesis
Time frame: 15 days
Total radioactivity concentration equivalents in plasma and blood
Time frame: 15 days
Plazomicin concentrations in plasma and urine
Time frame: 15 days
4 secondary outcomes
Incidence and severity of adverse events
Time frame: 21 days
Change from baseline in vital signs post dose (temperature, pulse, respiration, blood pressure)
Time frame: 1 day
Absolute values of and change from baseline in clinical laboratory values (hematology, serum chemistry, urine analysis)
Time frame: 4 days
Physical examination
Time frame: Screening
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 12 Jul 2017.
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Screening Protocol
Pain
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.
Shyeilla Dhuria study director
Achaogen, 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 [14C]-plazomicin in people with Healthy Volunteers, run by Achaogen, 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 1 inclusion and 5 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 12 Jul 2017. 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?
Sum of percent of total radioactivity recovered in urine and feces relative to the administered radioactive dose minus any radioactivity lost due to emesis (time frame: 15 days). The study lists 3 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 12 Jul 2017.