NCT00312182

Brief Summary

To assess if nelfinavir has any clinically meaninful effect on cardiac function, namely ECG evaluation

Trial Health

90
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P75+ for phase_4 healthy-volunteers

Timeline
Completed

Started Mar 2006

Shorter than P25 for phase_4 healthy-volunteers

Geographic Reach
3 countries

4 active sites

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

March 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 5, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 7, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

April 10, 2009

Status Verified

April 1, 2009

First QC Date

April 5, 2006

Last Update Submit

April 9, 2009

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • ECG evaluation

Secondary Outcomes (1)

  • Pharmacokinetics

Interventions

NelfinavirDRUG

Eligibility Criteria

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

You may qualify if:

  • Healthy male and female subjects between the ages of 18 and 55 years, inclusive. Body Mass Index (BMI) of approximately 18 to 30 kg/m2.

You may not qualify if:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Pfizer Investigational Site

New Haven, Connecticut, 06511-5473, United States

Location

Pfizer Investigational Site

Ann Arbor, Michigan, 48105, United States

Location

Pfizer Investigational Site

Brussels, B-1070, Belgium

Location

Pfizer Investigational Site

Singapore, 169608, Singapore

Location

Related Links

MeSH Terms

Interventions

Nelfinavir

Intervention Hierarchy (Ancestors)

IsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 5, 2006

First Posted

April 7, 2006

Study Start

March 1, 2006

Study Completion

June 1, 2006

Last Updated

April 10, 2009

Record last verified: 2009-04

Locations

US(2)BE(1)SG(1)