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Completed

NCT Number: NCT01290211

Pharmacokinetic Interaction Between Maraviroc And Fosamprenavir/Ritonavir In Healthy Subjects

This is will be an open-label, fixed-sequence, multiple dose crossover study in 2 cohorts of 14 healthy male and/or female subjects, to estimate the effect of maraviroc on the pharmacokinetics of amprenavir and ritonavir and fosamprenavir/ritonavir on the pharmacokinetics of maraviroc.

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Key information

Conditions

Healthy Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Brussels, B-1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
  • 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 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.
  • Positive result for HIV, Hepatitis B or Hepatitis C virus.
  • 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.
  • Known hypersensitivity or history of allergy to sulfonamides.

Treatment and study plan

Maraviroc

Drug

maraviroc 300 mg BID x 5 days

Other names: Selzentry, Celsentri

Fosamprenavir/Ritonavir

Drug

fosamprenavir/ritonavir 700/100 mg BID x 10 days

Maraviroc + Fosamprenavir/ritonavir

Drug

maraviroc 300 mg BID + fosamprenavir/ritonavir 700/100 mg BID x 10 days

Primary outcomes

  1. Maraviroc plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ.

    Time frame: Period 1, Day 5

  2. Maraviroc plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ.

    Time frame: Period 2, Day 20

  3. Amprenavir and ritonavir plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ.

    Time frame: Period 2, Day 10

  4. Amprenavir and ritonavir plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ.

    Time frame: Period 2, Day 20

Secondary outcomes

  1. Maraviroc plasma pharmacokinetic parameter: Tmax on Period 1, Day 5 and Period 2, Day 20.

    Time frame: Period 1, Day 5

  2. Maraviroc plasma pharmacokinetic parameter: Tmax on Period 1, Day 5 and Period 2, Day 20.

    Time frame: Period 2, Day 20

  3. Amprenavir and ritonavir plasma pharmacokinetic parameter: Tmax, on Period 2, Day 10 and Period 2, Day 20.

    Time frame: Period 2, Day 10

  4. Amprenavir and ritonavir plasma pharmacokinetic parameter: Tmax, on Period 2, Day 10 and Period 2, Day 20.

    Time frame: Period 2, Day 20

  5. Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments.

    Time frame: 25 Days

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Collaborators

  • Pfizer

Registry information

Official study title

Open-Label, Fixed-Sequence Study To Estimate The Pharmacokinetic Interaction Between Multiple Dose Maraviroc And Fosamprenavir/Ritonavir In Healthy Subjects

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 4, 2011
Registry last updated
Jun 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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