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Completed

NCT Number: NCT00722202

Study Evaluating the Safety and Pharmacokinetics (PK) of Ascending Single IV Doses of ERB-257 in Healthy Japanese Males

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of IV administered ERB-257 as single ascending doses to healthy Japanese male subjects

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Key information

Conditions

Healthy Subjects

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Sekino Clinical Pharmacology Clinic

Tokyo, 1710014, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy Japanese men between the ages of 20 and 50.
  • Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight greater than or equal to 45 kg2.
  • Have a high probability for compliance with and completion of the study.

Exclusion criteria

  • Presence or history of any disorder that may prevent the successful completion of the study.
  • Acute disease state (eg, nausea, vomiting, infection, fever, or diarrhea) within 7 days before study day 1.

Treatment and study plan

ERB-257

Drug

Placebo

Other

Primary outcomes

  1. To evaluate the safety and tolerability of ERB-257 as a single IV dose

    Time frame: 4 days

Secondary outcomes

  1. To evaluate the pharmacokinetics of ERB-257 as a single IV dose

    Time frame: 4 days

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

Ascending Single-Dose Study of the Safety, Tolerability, and Pharmacokinetics of ERB-257 Administered Intravenously as a 30-Minute Infusion to Healthy Japanese Male Subjects

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jul 25, 2008
Registry last updated
Apr 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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