Thorough QT Study of Nelfinavir

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00312182
• Collaborator: (none)
• Enrollment: 68
• Locations: 4
• Duration (Months): 3
• Patients Per Site: 17
• Patients Per Site Per Month: 5.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Nelfinavir	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 68 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Evaluation Of The Effect Of Nelfinavir On QT Intervals At Steady-State After Twice-Daily Administration Of Nelfinavir Tablets To Healthy Volunteers
• Study Start Date: Mar 1, 2006
• Actual Study Completion Date: Jun 1, 2006

Outcome Measures

Primary Outcome Measures

1. ECG evaluation []

Secondary Outcome Measures

1. Pharmacokinetics []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	New Haven	Connecticut	United States	06511-5473
2	Pfizer Investigational Site	Ann Arbor	Michigan	United States	48105
3	Pfizer Investigational Site	Bruxelles		Belgium	B-1070
4	Pfizer Investigational Site	Singapore		Singapore	169608

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00312182
• Other Study ID Numbers: A4301023
• First Posted: Apr 7, 2006
• Last Update Posted: Apr 10, 2009
• Last Verified: Apr 1, 2009

• Additional relevant MeSH terms: Nelfinavir

Study Results

No Results Posted as of Apr 10, 2009