Study Evaluating The Tolerability Of Multiple Doses Of HKI-272

Puma Biotechnology

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: neratinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00757809

3144A1-1116

Details and patient eligibility

About

Study to investigate the occurence of diarrhea after either once daily or twice daily dosing for 14 days.

Enrollment: 50 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Healthy male and female (non-child bearing potential) subjects
• Ages 18-50.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

QD

Experimental group

Description:

Once daily

Treatment:

Drug: neratinib

BID

Experimental group

Description:

Twice daily

Treatment:

Drug: neratinib