A Study to Assess the Effect of Plazomicin on the Pharmacokinetics of Metformin
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
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy-volunteers
Started Aug 2017
Shorter than P25 for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2017
CompletedStudy Start
First participant enrolled
August 31, 2017
CompletedFirst Posted
Study publicly available on registry
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 7, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 7, 2017
CompletedOctober 11, 2017
October 1, 2017
1 month
August 30, 2017
October 9, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Pharmacokinetics of metformin in plasma
9 days
Secondary Outcomes (5)
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
Study Arms (2)
Sequence 1
EXPERIMENTALIn Period 1, subjects receive metformin alone; in Period 2, subjects receive metformin + plazomicin
Sequence 2
EXPERIMENTALIn Period 1, subjects receive metformin + plazomicin; in Period 2, subjects receive metformin alone
Interventions
Eligibility Criteria
You may qualify if:
- Medically healthy, with no clinically significant medical history, physical examination findings, vital signs, or ECG findings
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Achaogen, Inc.lead
Study Sites (1)
Clinical Site
Lincoln, Nebraska, 68502, United States
Related Publications (1)
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.
PMID: 30605260DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Shyeilla Dhuria
Achaogen, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2017
First Posted
September 1, 2017
Study Start
August 31, 2017
Primary Completion
October 7, 2017
Study Completion
October 7, 2017
Last Updated
October 11, 2017
Record last verified: 2017-10