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OpenTrials
Completed

NCT Number: NCT00550381

Study Evaluating the Safety, Tolerability, and Pharmacokinetics (PK) of HKI-357 Administered Orally to Healthy Subjects

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of single doses of HKI-357 administered to healthy subjects.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

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

Eligibility Criteria:

  • Healthy adult men or women of nonchildbearing potential, aged 18-50.

Treatment and study plan

HKI-357

Drug

Single-dose capsule

Primary outcomes

  1. Safety, tolerability, PK

    Time frame: 5 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 HKI-357 Administered Orally to Healthy Subjects

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Oct 29, 2007
Registry last updated
Jul 10, 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.

Published trials that share one or more normalized conditions with this study.