Study to Estimate the Pharmacokinetics, Bioavailability and Effect of Food on Single Dose Modified-release Lersivirine 500 mg in Healthy Subjects
This study has been completed.
Sponsor:
Pfizer
Collaborator:
ViiV Healthcare
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01603485
First received: May 10, 2012
Last updated: September 18, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Volunteer |
Drug: Lersivirine Immediate-Release (fasted) Drug: Lersivirine Modified-Release #1 (fasted) Drug: Lersivirine Modified-Release #2 (fasted) Drug: Lersivirine Modified-Release #3 (fasted) Drug: Lersivirine Modified-Release (fed) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Bio-availability Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| 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 |
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Lersivirine Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] [ Time Frame: T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose ] [ Designated as safety issue: No ]
- Lersivirine Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose ] [ Designated as safety issue: No ]
- Lersivirine Maximum Observed Plasma Concentration (Cmax) [ Time Frame: T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Lersivirine Plasma Decay Half-Life (t1/2) [ Time Frame: T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose ] [ Designated as safety issue: No ]
- Lersivirine Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose ] [ Designated as safety issue: No ]
- Lersivirine Observed Plasma Concentration at time 24hr (C24) [ Time Frame: T = 24 hours post dose ] [ Designated as safety issue: No ]
- Lersivirine Last Observed Plasma Concentration (Clast) [ Time Frame: T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose ] [ Designated as safety issue: No ]
| Enrollment: | 16 |
| Study Start Date: | June 2012 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Lersivirine |
Drug: Lersivirine Immediate-Release (fasted)
Single 500 mg dose of Lersivirine Immediate-Release Tablets (2 x 250 mg)
Drug: Lersivirine Modified-Release #1 (fasted)
Single 500 mg dose of Lersivirine Modified-Release Tablet #1
Drug: Lersivirine Modified-Release #2 (fasted)
Single 500 mg dose of Lersivirine Modified-Release Tablet #2
Drug: Lersivirine Modified-Release #3 (fasted)
Single 500 mg dose of Lersivirine Modified-Release Tablet #3
Drug: Lersivirine Modified-Release (fed)
Single 500 mg dose of Lersivirine Modified-Release Tablet dosed with food.
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01603485 History of Changes |
| Other Study ID Numbers: | A5271050 |
| Study First Received: | May 10, 2012 |
| Last Updated: | September 18, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Bioavailability Pharmacokinetics Lersivirine Modified-release |
ClinicalTrials.gov processed this record on May 16, 2013