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

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Pfizer

Status and phase

Completed
Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Lersivirine
Drug: Abacavir/Lamivudine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01220232
A5271048

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

14 participants in 2 patient groups

Abacavir/Lamivudine
Active Comparator group
Treatment:
Drug: Abacavir/Lamivudine
Lersivirine + Abacavir/Lamivudine
Experimental group
Treatment:
Drug: Abacavir/Lamivudine
Drug: Lersivirine

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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