- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03270553
A Study to Assess the Effect of Plazomicin on the Pharmacokinetics of Metformin
October 9, 2017 updated by: Achaogen, Inc.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nebraska
-
Lincoln, Nebraska, United States, 68502
- Clinical Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Key Inclusion Criteria:
- Medically healthy, with no clinically significant medical history, physical examination findings, vital signs, or ECG findings
Key Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Sequence 1
In Period 1, subjects receive metformin alone; in Period 2, subjects receive metformin + plazomicin
|
single intravenous dose
single oral dose
|
EXPERIMENTAL: Sequence 2
In Period 1, subjects receive metformin + plazomicin; in Period 2, subjects receive metformin alone
|
single intravenous dose
single oral dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetics of metformin in plasma
Time Frame: 9 days
|
9 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence and severity of adverse events
Time Frame: 15 days
|
15 days
|
Change from baseline in vital signs post dose (temperature, pulse, respiration, blood pressure)
Time Frame: 8 days
|
8 days
|
Absolute values of and change from baseline in clinical laboratory values (hematology, serum chemistry, urine analysis)
Time Frame: 9 days
|
9 days
|
Pharmacokinetics of metformin in urine
Time Frame: 9 days
|
9 days
|
Pharmacokinetics of plazomicin in plasma
Time Frame: 9 days
|
9 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 31, 2017
Primary Completion (ACTUAL)
October 7, 2017
Study Completion (ACTUAL)
October 7, 2017
Study Registration Dates
First Submitted
August 30, 2017
First Submitted That Met QC Criteria
August 30, 2017
First Posted (ACTUAL)
September 1, 2017
Study Record Updates
Last Update Posted (ACTUAL)
October 11, 2017
Last Update Submitted That Met QC Criteria
October 9, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACHN-490-011
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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