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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03270553
• Other study ID #: ACHN-490-011
• Status: Completed
• Phase: Phase 1
• First received: August 30, 2017
• Last updated: October 9, 2017
• Start date: August 31, 2017
• Est. completion date: October 7, 2017

Study information

• Verified date: October 2017
• Source: Achaogen, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 7, 2017
• Est. primary completion date: October 7, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• plazomicin
single intravenous dose
• metformin
single oral dose

Locations

Country	Name	City	State
United States	Clinical Site	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Achaogen, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of metformin in plasma		9 days
Secondary	Incidence and severity of adverse events		15 days
Secondary	Change from baseline in vital signs post dose (temperature, pulse, respiration, blood pressure)		8 days
Secondary	Absolute values of and change from baseline in clinical laboratory values (hematology, serum chemistry, urine analysis)		9 days
Secondary	Pharmacokinetics of metformin in urine		9 days
Secondary	Pharmacokinetics of plazomicin in plasma		9 days