Status:
COMPLETED
A Study to Assess the Effect of Plazomicin on the Pharmacokinetics of Metformin
Lead Sponsor:
Achaogen, Inc.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
19-55 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- Key
- Medically healthy, with no clinically significant medical history, physical examination findings, vital signs, or ECG findings
- Key
Exclusion
- 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
Key Trial Info
Start Date :
August 31 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 7 2017
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03270553
Start Date
August 31 2017
End Date
October 7 2017
Last Update
October 11 2017
Active Locations (1)
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1
Clinical Site
Lincoln, Nebraska, United States, 68502