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

Ascending Single-Dose Study of the Safety, Tolerability, and Pharmacokinetics of HKI-357 Administered Orally to Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00550381

Enrollment

Registered

2007-10-29

Start date

2008-01-31

Completion date

2008-03-31

Last updated

2009-07-10

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

Conditions

Healthy

Keywords

healthy subjects

Brief summary

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

Interventions

DRUGHKI-357

Single-dose capsule

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

Eligibility Criteria: * Healthy adult men or women of nonchildbearing potential, aged 18-50.

Design outcomes

Primary

Measure	Time frame
Safety, tolerability, PK	5 days

Outcome results

None listed

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