HKI-272 Ketoconazole Drug Interaction Study

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00380328

Enrollment

Registered

2006-09-25

Start date

2006-10-31

Completion date

2006-11-30

Last updated

2012-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Pharmacokinetic, healthy subjects

Brief summary

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

Interventions

DRUGneratinib

HKI-272

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics; safety and tolerability	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026