NCT01603485

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

May 10, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 22, 2012

Completed
10 days until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

September 19, 2012

Status Verified

September 1, 2012

Enrollment Period

2 months

First QC Date

May 10, 2012

Last Update Submit

September 18, 2012

Conditions

Healthy Volunteer

Keywords

BioavailabilityPharmacokineticsLersivirineModified-release

Outcome Measures

Primary Outcomes (3)

  • Lersivirine Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]

    T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose

  • 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

  • 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

Secondary Outcomes (4)

  • 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

  • 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

  • Lersivirine Observed Plasma Concentration at time 24hr (C24)

    T = 24 hours post dose

  • 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

Study Arms (1)

Lersivirine

EXPERIMENTAL
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)

Interventions

Lersivirine Immediate-Release (fasted)DRUG

Single 500 mg dose of Lersivirine Immediate-Release Tablets (2 x 250 mg)

Lersivirine
Lersivirine Modified-Release #1 (fasted)DRUG

Single 500 mg dose of Lersivirine Modified-Release Tablet #1

Lersivirine
Lersivirine Modified-Release #2 (fasted)DRUG

Single 500 mg dose of Lersivirine Modified-Release Tablet #2

Lersivirine
Lersivirine Modified-Release #3 (fasted)DRUG

Single 500 mg dose of Lersivirine Modified-Release Tablet #3

Lersivirine
Lersivirine Modified-Release (fed)DRUG

Single 500 mg dose of Lersivirine Modified-Release Tablet dosed with food.

Lersivirine

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Brussels, B-1070, Belgium

Location

Related Links

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2012

First Posted

May 22, 2012

Study Start

June 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

September 19, 2012

Record last verified: 2012-09

Locations

BE(1)