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

Achaogen

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: metformin; Drug: plazomicin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03270553

ACHN-490-011

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Sequence 1

Experimental group

Description:

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

Treatment:

Drug: plazomicin

Drug: metformin

Sequence 2

Experimental group

Description:

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

Treatment:

Drug: plazomicin

Drug: metformin