Estimate The Effect Of Lersivirine On The Pharmacokinetics Of Abacavir/Lamivudine In Healthy Subjects

Healthy Volunteers Clinical Trial

Official title:

Open-Label, Fixed-Sequence, Crossover Study To Estimate The Effect Of Lersivirine On The Pharmacokinetics Of Abacavir/Lamivudine In Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01220232
• Other study ID #: A5271048
• Status: Completed
• Phase: Phase 1
• First received: October 12, 2010
• Last updated: February 3, 2011
• Start date: November 2010
• Est. completion date: January 2011

Study information

• Verified date: February 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This will be an open-label, fixed-sequence, multiple dose crossover study in 14 healthy male and/or female subjects, to estimate the effect of steady state lersivirine on the steady state pharmacokinetics of abacavir/lamivudine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male and/or female subjects.

• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.

• Total body weight >50 kg (110 lbs).

Exclusion Criteria:

• History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.

• Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.

• Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.

• History of hypersensitivity to abacavir, lamivudine and/or lersivirine.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Abacavir/Lamivudine
Abacavir/Lamivudine 600/300 mg QD for 5 days
• Abacavir/Lamivudine
Abacavir/Lamivudine 600/300 mg QD for 10 days
• Lersivirine
Lersivirine 750 mg QD for 10 days

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	ViiV Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To estimate the effect of steady state lersivirine 750 mg on the steady state pharmacokinetics of abacavir/lamivudine.		17 days	No
Secondary	To investigate the safety and tolerability of lersivirine when co-administered with abacavir/lamivudine.		17 days	Yes

External Links

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