Healthy Volunteers
Conditions
Brief 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.
Interventions
DRUGplazomicin
single intravenous dose
DRUGmetformin
single oral dose
Sponsors
Achaogen, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of metformin in plasma | 9 days |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events | 15 days |
| Change from baseline in vital signs post dose (temperature, pulse, respiration, blood pressure) | 8 days |
| Absolute values of and change from baseline in clinical laboratory values (hematology, serum chemistry, urine analysis) | 9 days |
| Pharmacokinetics of metformin in urine | 9 days |
| Pharmacokinetics of plazomicin in plasma | 9 days |
Countries
United States
Outcome results
None listed