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

October 9, 2017 updated by: Achaogen, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Nebraska
      • Lincoln, Nebraska, United States, 68502
        • Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Sequence 1
In Period 1, subjects receive metformin alone; in Period 2, subjects receive metformin + plazomicin
single intravenous dose
single oral dose
EXPERIMENTAL: Sequence 2
In Period 1, subjects receive metformin + plazomicin; in Period 2, subjects receive metformin alone
single intravenous dose
single oral dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics of metformin in plasma
Time Frame: 9 days
9 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 31, 2017

Primary Completion (ACTUAL)

October 7, 2017

Study Completion (ACTUAL)

October 7, 2017

Study Registration Dates

First Submitted

August 30, 2017

First Submitted That Met QC Criteria

August 30, 2017

First Posted (ACTUAL)

September 1, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 11, 2017

Last Update Submitted That Met QC Criteria

October 9, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • ACHN-490-011

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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