Clinical trial NCT01407016: A Study To Assess The Safety, Tolerability And Pharmacokinetics Of Metronidazole Injection In Healthy Japanese Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infection
Keywords: metronidazole infusion
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-08-01
Enrollment: 6
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Plasma metronidazole pharmacokinetic parameters for single dose:Cmax
timeFrame: Day 1 to Day 3
measure: Plasma metronidazole pharmacokinetic parameters for single dose:AUClast
timeFrame: Day 1 to Day 3
measure: Plasma metronidazole pharmacokinetic parameters for single dose:AUC0-6
timeFrame: Day 1 to Day 3
measure: Plasma metronidazole pharmacokinetic parameters for single dose:Tmax
timeFrame: Day 1 to Day 3
measure: Plasma metronidazole pharmacokinetic parameters for multiple dose:Ctrough
timeFrame: prior to Day 3 and Day 6-8 morning dose and 6 hours post morning dose on Day 8
measure: Plasma metronidazole pharmacokinetic parameters for multiple dose:Cmax
timeFrame: Day 8 to Day 9
measure: Plasma metronidazole pharmacokinetic parameters for multiple dose:AUC0-6
timeFrame: Day 8 to Day 9
measure: Plasma metronidazole pharmacokinetic parameters for multiple dose:Tmax
timeFrame: Day 8 to Day 9
measure: Plasma metronidazole pharmacokinetic parameters for multiple dose:CL
timeFrame: Day 8 to Day 9
Secondary outcomes:
measure: Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: Cmax
timeFrame: Day 1 to Day 3
measure: Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: AUClast
timeFrame: Day 1 to Day 3
measure: Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: AUC0-6
timeFrame: Day 1 to Day 3
measure: Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: Tmax
timeFrame: Day 1 to Day 3
measure: Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for multiple dose: Ctrough
timeFrame: prior to Day 3 and Day 6-8 morning dose and 6 hours post morning dose on Day 8
measure: Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for multiple dose: Cmax
timeFrame: Day 8 to Day 9
measure: Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for multiple dose: AUC0-6
timeFrame: Day 8 to Day 9
measure: Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for multiple dose: Tmax
timeFrame: Day 8 to Day 9
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: