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Study Evaluating The Potential Effect Of Rifampin On The Pharmacokinetics Of Neratinib

A Study to Examine the Potential Effect of Rifampin on the Pharmacokinetics of Neratinib When Administered Concomitantly to Healthy Subjects

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00864487
Enrollment
24
Registered
2009-03-18
Start date
2009-04-30
Completion date
2009-05-31
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 Subjects

Brief summary

The purpose of this study is to examine whether co-administration of rifampin with neratinib has an effect on the pharmacokinetics (how the body absorbs, distributes, metabolizes and/or excretes) of neratinib.

Interventions

DRUGNeratinib

HKI-272

Sponsors

Puma Biotechnology, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NON_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 men or women (of non childbearing potential) * Ages 18 to 50 years old.

Design outcomes

Primary

MeasureTime frame
Pharmacokinetics (plasma blood concentrations)4 weeks

Countries

United States

Outcome results

None listed

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