HKI-272 Ketoconazole Drug Interaction Study

To investigate a potential pharmacokinetic drug interaction between HKI-272 and ketoconazole when co-administered.

Completed

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Key information

Conditions

Healthy

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.

Inclusion criteria

Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead ECG.

Treatment and study plan

Neratinib

Drug

HKI-272

Primary outcomes

Pharmacokinetics; safety and tolerability

Sponsors and collaborators

Lead sponsor

Puma Biotechnology, Inc.

Industry

Registry information

Official study title

An Open-label, Randomized, 2-period Crossover, Drug Interaction Study to Evaluate the Potential Pharmacokinetic Interaction Between Multiple Doses of Ketoconazole and a Single Dose of HKI-272 Administered Orally to Healthy Subjects

Important dates

Study start: 2006
Study completion: 2006
First posted: Sep 25, 2006
Registry last updated: May 14, 2012

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.

Completed