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Completed

NCT Number: NCT03270553

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Site

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

plazomicin

Drug

single intravenous dose

metformin

Drug

single oral dose

Primary outcomes

  1. Pharmacokinetics of metformin in plasma

    Time frame: 9 days

Secondary outcomes

  1. Incidence and severity of adverse events

    Time frame: 15 days

  2. Change from baseline in vital signs post dose (temperature, pulse, respiration, blood pressure)

    Time frame: 8 days

  3. Absolute values of and change from baseline in clinical laboratory values (hematology, serum chemistry, urine analysis)

    Time frame: 9 days

  4. Pharmacokinetics of metformin in urine

    Time frame: 9 days

  5. Pharmacokinetics of plazomicin in plasma

    Time frame: 9 days

Sponsors and collaborators

Lead sponsor

Achaogen, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 1, 2017
Registry last updated
Oct 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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