Healthy VolunteersPhase 1NCT03270553
A Study to Assess the Effect of Plazomicin on the Pharmacokinetics of Metformin
A Phase 1 study testing plazomicin and metformin in people with Healthy Volunteers, run by Achaogen, Inc. at 1 site in United States.
Trial summary
This is a single-center, Phase 1, open label, randomized, two-sequence, two-period, crossover study to evaluate the drug-drug interaction potential between plazomicin and metformin in healthy subjects. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- plazomicin and metformin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2017to 7 Oct 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
- All sexes
- 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
- Estimated creatinine clearance <90 mL/min
- Use of tobacco- or nicotine-containing products
- 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
- History of hearing loss or a family history of hearing loss, or a prior diagnosis of sensorineural hearing loss or Ménière's disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open Label, Randomized, 2-Period, 2-Treatment, Crossover Study to Assess the Effect of Plazomicin on the Pharmacokinetics of Metformin in Healthy Subjects
This is a single-center, Phase 1, open label, randomized, two-sequence, two-period, crossover study to evaluate the drug-drug interaction potential between plazomicin and metformin in healthy subjects.
- Conditions
- Healthy Volunteers
- Being tested
- plazomicin, metformin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plazomicinDrug
single intravenous dose
metforminDrug
single oral dose
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | In Period 1, subjects receive metformin alone; in Period 2, subjects receive metformin + plazomicin Receives: Drug: plazomicin; Drug: metformin |
| Sequence 2 | Experimental | In Period 1, subjects receive metformin + plazomicin; in Period 2, subjects receive metformin alone Receives: Drug: plazomicin; Drug: metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of metformin in plasma
Measured: 9 days
Secondary outcomes (5)
Incidence and severity of adverse events
Measured: 15 days
Change from baseline in vital signs post dose (temperature, pulse, respiration, blood pressure)
Measured: 8 days
Absolute values of and change from baseline in clinical laboratory values (hematology, serum chemistry, urine analysis)
Measured: 9 days
Pharmacokinetics of metformin in urine
Measured: 9 days
Pharmacokinetics of plazomicin in plasma
Measured: 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start31 Aug 2017
- Primary completion7 Oct 2017
- Study completion7 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Achaogen, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shyeilla Dhuria, Study director, Achaogen, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03270553
- Sponsor's protocol ID
- ACHN-490-011
- Status last verified
- Oct 2017
- First submitted
- 30 Aug 2017
- Last updated
- 11 Oct 2017
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Choi T, Komirenko AS, Riddle V, Kim A, Dhuria SV. No Effect of Plazomicin on the Pharmacokinetics of Metformin in Healthy Subjects. Clin Pharmacol Drug Dev. 2019 Aug;8(6):818-826. doi: 10.1002/cpdd.648. Epub 2019 Jan 3.
PubMed 30605260
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, Randomized, 2-Period, 2-Treatment, Crossover Study to Assess the Effect of Plazomicin on the Pharmacokinetics of Metformin in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03270553
- Acronym / sponsor ID
- ACHN-490-011
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Achaogen, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2017 (actual)
- Primary completion
- 7 Oct 2017 (actual)
- Study completion
- 7 Oct 2017 (actual)
- First posted
- 1 Sep 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, Phase 1, open label, randomized, two-sequence, two-period, crossover study to evaluate the drug-drug interaction potential between plazomicin and metformin in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: plazomicin, Drug: metforminIn Period 1, subjects receive metformin alone; in Period 2, subjects receive metformin + plazomicin |
| Sequence 2 | Experimental | Drug: plazomicin, Drug: metforminIn Period 1, subjects receive metformin + plazomicin; in Period 2, subjects receive metformin alone |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- 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)
- Estimated creatinine clearance <90 mL/min
- Use of tobacco- or nicotine-containing products
- 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
- History of hearing loss or a family history of hearing loss, or a prior diagnosis of sensorineural hearing loss or Ménière's disease
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 |
|---|---|---|
| plazomicinsingle intravenous dose | Drug | Sequence 1, Sequence 2 |
| metforminsingle oral dose | Drug | Sequence 1, Sequence 2 |
Primary outcome
Pharmacokinetics of metformin in plasma
Time frame: 9 days
5 secondary outcomes
Incidence and severity of adverse events
Time frame: 15 days
Change from baseline in vital signs post dose (temperature, pulse, respiration, blood pressure)
Time frame: 8 days
Absolute values of and change from baseline in clinical laboratory values (hematology, serum chemistry, urine analysis)
Time frame: 9 days
Pharmacokinetics of metformin in urine
Time frame: 9 days
Pharmacokinetics of plazomicin in plasma
Time frame: 9 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 11 Oct 2017.
- Derived from this study: PubMed 30605260Choi T, Komirenko AS, Riddle V, Kim A, Dhuria SV. No Effect of Plazomicin on the Pharmacokinetics of Metformin in Healthy Subjects. Clin Pharmacol Drug Dev. 2019 Aug;8(6):818-826. doi: 10.1002/cpdd.648. Epub 2019 Jan 3.
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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.
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 plazomicin and metformin 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 11 Oct 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?
Pharmacokinetics of metformin in plasma (time frame: 9 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03270553, which also lists 1 linked publication.
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 11 Oct 2017.