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

NCT ID: NCT03270553

Last Updated: 2017-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-31

Study Completion Date

2017-10-07

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence 1

In Period 1, subjects receive metformin alone; in Period 2, subjects receive metformin + plazomicin

Group Type EXPERIMENTAL

plazomicin

Intervention Type DRUG

single intravenous dose

metformin

Intervention Type DRUG

single oral dose

Sequence 2

In Period 1, subjects receive metformin + plazomicin; in Period 2, subjects receive metformin alone

Group Type EXPERIMENTAL

plazomicin

Intervention Type DRUG

single intravenous dose

metformin

Intervention Type DRUG

single oral dose

Interventions

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plazomicin

single intravenous dose

Intervention Type DRUG

metformin

single oral dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Medically healthy, with no clinically significant medical history, physical examination findings, vital signs, or ECG findings

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Achaogen, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shyeilla Dhuria

Role: STUDY_DIRECTOR

Achaogen, Inc.

Locations

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Clinical Site

Lincoln, Nebraska, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 30605260 (View on PubMed)

Other Identifiers

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ACHN-490-011

Identifier Type: -

Identifier Source: org_study_id