NCT01407016

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 1, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

September 28, 2011

Status Verified

September 1, 2011

Enrollment Period

1 month

First QC Date

July 20, 2011

Last Update Submit

September 27, 2011

Conditions

Infection

Keywords

metronidazole infusion

Outcome Measures

Primary Outcomes (9)

  • 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 Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (1)

1.0

EXPERIMENTAL
Drug: metronidazole IV 500 mg

Interventions

metronidazole IV 500 mgDRUG

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.

1.0

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Japanese male and/or female subjects.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Tokyo, Japan

Location

Related Links

MeSH Terms

Conditions

Infections

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2011

First Posted

August 1, 2011

Study Start

August 1, 2011

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

September 28, 2011

Record last verified: 2011-09

Locations

JP(1)