Pharmacokinetic Interaction Between Maraviroc And Fosamprenavir/Ritonavir In Healthy Subjects

NCT01140412 | Terminated Phase 1

• 1 other identifier: A4001099
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

maraviroc; fosamprenavir; drug interaction; pharmacokinetics; HIV; AIDS; CCR5; protease inhibitor

Outcome Measures

Primary Outcomes (2)

• Maraviroc plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ on Period 1, Day 5 and Period 2, Day 20

  25 days

• Amprenavir and ritonavir plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ on Period 2, Day 10 and Period 2, Day 20

  25 days

Secondary Outcomes (3)

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

  25 days

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

  25 days

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

  25 days

Study Arms (2)

Cohort 1

EXPERIMENTAL

Twice daily regimen

Drug: Maraviroc; Drug: Fosamprenavir/ritonavir; Drug: Maraviroc + Fosamprenavir/ritonavir

Cohort 2

EXPERIMENTAL

Once daily regimen

Drug: Maraviroc; Drug: Fosamprenavir/ritonavir; Drug: Maraviroc + Fosamprenavir/ritonavir

Interventions

Maraviroc DRUG

maraviroc 300 mg BID x 5 days

Also known as: Selzentry, Celsentri

Cohort 1

Fosamprenavir/ritonavir DRUG

fosamprenavir/ritonavir 700/100 mg BID x 10 days

Cohort 1

Maraviroc + Fosamprenavir/ritonavir DRUG

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

Cohort 1

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive.
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
• Total body weight \>45 kg (99 lbs).

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.
• 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.
• Known hypersensitivity or history of allergy to sulfonamides.

Sponsors & Collaborators

• ViiV Healthcare: lead
• Pfizer: collaborator

Study Sites (1)

Pfizer Investigational Site

Singapore, 188770, Singapore

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Maraviroc; fosamprenavir; Ritonavir

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Sulfur Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 7, 2010
• First Posted: June 9, 2010
• Study Start: July 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: February 4, 2011

Record last verified: 2011-02

Locations

SG (1)