Study Evaluating The Potential Effect Of Multiple Doses O... | NCT00860223

Studies
Study Evaluating The Potential Effect Of Multiple Doses Of Neratinib On The Pharmacokinetics Of A Single Dose Of Digoxin

NCT00860223

Sponsor

Puma Biotechnology, Inc.

Status

Completed

Last Update Posted

May 14, 2012Estimated

Enrollment

27Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Digoxin
Neratinib

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Apr 2009Actual

Completion Date

Apr 2009Actual

First Submitted Date

Mar 11, 2009

First Submission Date that Met QC Criteria

Mar 11, 2009

First Posted Date

Mar 12, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2012

Last Update Posted Date

May 14, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the potential effect of multiple doses of neratinib on the pharmacokinetics (how the body absorbs, distributes, metabolizes and/or excretes) of a single dose of digoxin.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Digoxin alone	Drug: Digoxin
2	Experimental	Digoxin plus neratinib	Drug: Digoxin Drug: Neratinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Digoxin	Drug		1 2
Neratinib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetic parameters: concentration of digoxin in blood and urine		5 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Healthy men and women of non-childbearing potential, age 18-50

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Puma	Biotechnology	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Miami	Florida	33126	United States

Intervention Browse Module

MeSH Terms

ID	Term
D004077	Digoxin
C487932	neratinib

Ancestor Terms

ID	Term
D004071	Digitalis Glycosides
D002298	Cardenolides
D002301	Cardiac Glycosides
D002297	Cardanolides

Browse Leaves

Not provided

Browse Branches

Not provided