MedDataX Logo

Study Evaluating The Effect Of A High-Fat Meal On The Pharmacokinetics Of Neratinib

NCT ID: NCT00932464

Last Updated: 2012-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2012-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is being conducted to see if neratinib is absorbed, distributed, or eliminated differently when administered in the fasting state versus after a high-fat meal.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Explore the Effect of Food Before a Single Dose of Sitravatinib

NCT04800614

Healthy Adults
COMPLETED PHASE1

A Study to Evaluate the Effect of Food on the Drug Levels of BMS-986196 in Healthy Adult Participants

NCT06034899

Healthy Adult Volunteers
WITHDRAWN PHASE1

A Study in Healthy Volunteers to Assess the Effect of Different Types of Food on a Single-dose of JNJ-64417184 Administered as Tablets

NCT04121052

Healthy
COMPLETED PHASE1

Effect of a High-fat Meal on the Pharmacokinetics of Hetrombopag and Mass Balance Study in Healthy Subjects

NCT02409394

Healthy
COMPLETED PHASE1

A Study to Evaluate the Effect of Food on Nemtabrutinib (MK-1026) in Healthy Participants (MK-1026-017)

NCT06772818

Healthy
COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Neratinib Fasted

Group Type EXPERIMENTAL

Neratinib

Intervention Type DRUG

240-mg oral tablet; single dose under fasted conditions

2

Neratinib Fed

Group Type EXPERIMENTAL

Neratinib

Intervention Type DRUG

240-mg oral tablet; single dose with high-fat breakfast

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Neratinib

240-mg oral tablet; single dose under fasted conditions

Intervention Type DRUG

Neratinib

240-mg oral tablet; single dose with high-fat breakfast

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

HKI-272 HKI-272

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy men and women of nonchildbearing potential, age 18 to 50 years.

Exclusion Criteria

* Any previous or current clinically significant medical condition or disease.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Puma Biotechnology, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Puma

Role: STUDY_DIRECTOR

Biotechnology

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B1891007

Identifier Type: -

Identifier Source: secondary_id

3144A2-1112

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effect of Low-fat Diet on the Pharmacokinetics of Pyrotinib in Healthy Participants
NCT04315493 UNKNOWN PHASE1
Effect of a High-fat Meal on the Pharmacokinetics of SHR3824 and Mass Balance Study in Healthy Subjects
NCT02353975 COMPLETED PHASE1
A Study to Characterize the Pharmacokinetics and Effect of Food on JNJ-31001074 in Healthy Volunteers
NCT00915434 COMPLETED PHASE1
Study Evaluating HKI-272 Administered to Healthy Subjects
NCT00366600 COMPLETED PHASE1
A Study to Evaluate the Effect of Food on Nemtabrutinib (MK-1026) in Healthy Participants (MK-1026-016)
NCT06772805 COMPLETED PHASE1
A Study to Assess the Effect of a High Fat Meal on Surufatinib in Healthy Subjects
NCT04372394 COMPLETED PHASE1
A Study to Investigate the Safety and Effect of Food on the Pharmacokinetics of YM178 in Healthy Volunteers
NCT01334905 COMPLETED PHASE1
Effect of Food on PC14586 in Healthy Volunteers and the PK of PC14586 in Healthy Japanese Volunteers
NCT05249348 COMPLETED PHASE1
A Food Effect Study of LP-168 Tablets in Healthy Subjects
NCT05917964 COMPLETED PHASE1
A Study to Assess the Effect of Food With Fezolinetant in Healthy Female Participants
NCT04641260 COMPLETED PHASE1
A Single Dose Study Of PF-04620110 In Healthy Subjects
NCT01166217 COMPLETED PHASE1
A Clinical Study of Enlicitide and the Effect of Food in Healthy Adult Participants (MK-0616-033)
NCT06609512 COMPLETED PHASE1
Study to Evaluate Potential Food Effects
NCT00791817 COMPLETED PHASE1
Study to Evaluate the Food Effect of Single-dose Bioavailability of Pracinostat in Healthy Adult Subjects
NCT02058784 COMPLETED EARLY_PHASE1
The Food Effect on Pharmacokinetics of DA-302168S
NCT06534346 COMPLETED PHASE1
A Food Effect Study of SHR1459 on Healthy Chinese Adult Subjects
NCT04291846 COMPLETED PHASE1
A Study of JNJ-64140284 Solid Dose Formulations in Healthy Male Participants
NCT04033458 TERMINATED PHASE1
A Study to Determine the Effect of a High-Fat Meal on the Rate and Extent of E2006 Absorption in Healthy Subjects
NCT02089412 COMPLETED PHASE1
Food Effect Study on the Bioavailability and PK of PA-824 Tablets in Healthy Adult Subjects (CL-009)
NCT01830439 COMPLETED PHASE1
Evaluation Of The Potential Effect That The Administration Of Food Or Antacid Medication May Have In The Oral Absorption Of Dacomitinib (PF-00299804)
NCT01702506 COMPLETED PHASE1
Single Dose Study To Study The Absorption, Metabolism And Excretion Of Famitinib
NCT05473468 UNKNOWN PHASE1
A Study of JNJ-64417184, Administered as an Oral Solution, in Healthy Participants
NCT04258189 COMPLETED PHASE1
A Phase 1, Pharmacokinetics of the MMP-12 Inhibitor FP-025 After Multiple Oral Ascending Doses in Healthy Subjects
NCT03304964 COMPLETED PHASE1
Food Effect Study to Evaluate the Effect of High-Fat Meal on the Relative Bioavailability of PF-07321332 Boosted With Ritonavir in Healthy Adult Participants
NCT05129475 COMPLETED PHASE1
A Phase 1 Study To Estimate The Relative Bioavailability And Food Effect Of PF-04620110 In Healthy Adult Subjects
NCT01064492 COMPLETED PHASE1