Study Evaluating HKI-272 Administered to Healthy Subjects

Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HKI-272 Administered Orally to Healthy Subjects.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00366600

Enrollment

Registered

2006-08-21

Start date

2006-07-31

Completion date

2006-12-31

Last updated

2017-09-11

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

Conditions

Healthy

Keywords

Breast Cancer, Health, Pharmacokinetics, healthy subjects

Brief summary

Safety and tolerability of HKI-272 in healthy subjects; the influence of food intake on the same.

Interventions

DRUGneratinib

HKI-272

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics; safety and tolerability; influence of food on the same.	—

Countries

United States

Outcome results

None listed

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