A Study To Assess The Safety, Tolerability And Pharmacokinetics Of Metronidazole Injection In Healthy Japanese Subjects

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety, tolerability and pharmacokinetics of metronidazole following single and multiple intravenous infusion in healthy Japanese adult subjects.

Official Title
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A Phase 1, Open Study To Assess The Safety, Tolerability And Pharmacokinetics Of Metronidazole Following Single And Multiple Intravenous Infusion In Healthy Japanese Adult Subjects

Conditions
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Infection

Intervention / Treatment
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* Drug: metronidazole IV 500 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Japanese male and/or female subjects. Exclusion Criteria: Subject with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). Subject with history of regular alcohol consumption exceeding 7 drink/week for females or 14 drinks/week for males [1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor] within 6 months of screening.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1.0<br> | Drug: metronidazole IV 500 mg<br>* On Day 1, subjects will receive a single dose of 500 mg metronidazole by intravenous infusion over 20 minutes. On Day 3 to Day 7, subjects will receive multiple doses of 500 mg metronidazole by intravenous infusion over 20 minutes 4 times a day (every 6 hours) for 5 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma metronidazole pharmacokinetic parameters for single dose:Cmax |  | Day 1 to Day 3 | 
| Plasma metronidazole pharmacokinetic parameters for single dose:AUClast |  | Day 1 to Day 3 | 
| Plasma metronidazole pharmacokinetic parameters for single dose:AUC0-6 |  | Day 1 to Day 3 | 
| Plasma metronidazole pharmacokinetic parameters for single dose:Tmax |  | Day 1 to Day 3 | 
| Plasma metronidazole pharmacokinetic parameters for multiple dose:Ctrough |  | prior to Day 3 and Day 6-8 morning dose and 6 hours post morning dose on Day 8 | 
| Plasma metronidazole pharmacokinetic parameters for multiple dose:Cmax |  | Day 8 to Day 9 | 
| Plasma metronidazole pharmacokinetic parameters for multiple dose:AUC0-6 |  | Day 8 to Day 9 | 
| Plasma metronidazole pharmacokinetic parameters for multiple dose:Tmax |  | Day 8 to Day 9 | 
| Plasma metronidazole pharmacokinetic parameters for multiple dose:CL |  | Day 8 to Day 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: Cmax |  | Day 1 to Day 3 | 
| Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: AUClast |  | Day 1 to Day 3 | 
| Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: AUC0-6 |  | Day 1 to Day 3 | 
| Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: Tmax |  | Day 1 to Day 3 | 
| Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for multiple dose: Ctrough |  | prior to Day 3 and Day 6-8 morning dose and 6 hours post morning dose on Day 8 | 
| Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for multiple dose: Cmax |  | Day 8 to Day 9 | 
| Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for multiple dose: AUC0-6 |  | Day 8 to Day 9 | 
| Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for multiple dose: Tmax |  | Day 8 to Day 9 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metronidazole infusion