A Study to Assess the Effect of Plazomicin on the Pharmacokinetics of Metformin

• Status: Completed
• Trial end date: 2017-10-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Achaogen, Inc.
• Treatments: Metformin

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