Study to Estimate the Pharmacokinetics, Bioavailability and Effect of Food on Single Dose Modified-release Lersivirine 500 mg in Healthy Subjects

Healthy Volunteer Clinical Trial

Official title:

Open-Label, Randomized, Crossover Study to Estimate the Pharmacokinetics, Bioavailability and Effect of Food on Single Dose Modified-Release Lersivirine (UK-453,061) 500 mg in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01603485
• Other study ID #: A5271050
• Status: Completed
• Phase: Phase 1
• First received: May 10, 2012
• Last updated: September 18, 2012
• Start date: June 2012
• Est. completion date: August 2012

Study information

• Verified date: September 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to estimate the pharmacokinetics (PK) of 3 different modified-release formulations of lersivirine and compare it to the PK of the immediate-release tablet. The effect of food on the PK of one of the modified-release tablets will also be assess along with the safety and tolerability of each treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

• Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

• History of regular alcohol consumption exceeding 14 drinks/week for females or 21 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;

• Treatment with an investigational drug within 60 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication;

• Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.

Study Design

Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• Lersivirine Immediate-Release (fasted)
Single 500 mg dose of Lersivirine Immediate-Release Tablets (2 x 250 mg)
• Lersivirine Modified-Release #1 (fasted)
Single 500 mg dose of Lersivirine Modified-Release Tablet #1
• Lersivirine Modified-Release #2 (fasted)
Single 500 mg dose of Lersivirine Modified-Release Tablet #2
• Lersivirine Modified-Release #3 (fasted)
Single 500 mg dose of Lersivirine Modified-Release Tablet #3
• Lersivirine Modified-Release (fed)
Single 500 mg dose of Lersivirine Modified-Release Tablet dosed with food.

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Bruxelles

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	ViiV Healthcare

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lersivirine Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]		T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose	No
Primary	Lersivirine Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)		T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose	No
Primary	Lersivirine Maximum Observed Plasma Concentration (Cmax)		T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose	No
Secondary	Lersivirine Plasma Decay Half-Life (t1/2)		T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose	No
Secondary	Lersivirine Time to Reach Maximum Observed Plasma Concentration (Tmax)		T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose	No
Secondary	Lersivirine Observed Plasma Concentration at time 24hr (C24)		T = 24 hours post dose	No
Secondary	Lersivirine Last Observed Plasma Concentration (Clast)		T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose	No

External Links

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