NCT00251030

Brief Summary

To estimate the effects of omeprazole on the pharmacokinetics of nelfinavir in healthy subjects

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_4 healthy-volunteers

Timeline
Completed

Started Nov 2005

Shorter than P25 for phase_4 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 9, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

February 16, 2009

Status Verified

February 1, 2009

First QC Date

November 8, 2005

Last Update Submit

February 13, 2009

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • To estimate the effects of multiple doses of omeprazole on the steady-state pharmacokinetics of nelfinavir and M8 in healthy subjects

Secondary Outcomes (1)

  • To evaluate the safety and tolerability of the 625 mg formulation of nelfinavir when administered alone and with omeprazole

Interventions

Nelfinavir and OmeprazoleDRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male or female subjects between the ages of 18 and 55 years.

You may not qualify if:

  • Subjects with hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Kalamazoo, Michigan, 49007, United States

Location

MeSH Terms

Interventions

NelfinavirOmeprazole

Intervention Hierarchy (Ancestors)

IsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingBenzimidazoles

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 8, 2005

First Posted

November 9, 2005

Study Start

November 1, 2005

Study Completion

January 1, 2006

Last Updated

February 16, 2009

Record last verified: 2009-02

Locations

US(1)