Pharmacokinetic Interaction Between Maraviroc And Fosamprenavir/Ritonavir In Healthy Subjects

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01140412
• Other study ID #: A4001099
• Status: Terminated
• Phase: Phase 1
• First received: June 7, 2010
• Last updated: February 3, 2011
• Start date: July 2010
• Est. completion date: October 2010

Study information

• Verified date: February 2011
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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).

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.

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Maraviroc
maraviroc 300 mg BID x 5 days
• Fosamprenavir/ritonavir
fosamprenavir/ritonavir 700/100 mg BID x 10 days
• Maraviroc + Fosamprenavir/ritonavir
maraviroc 300 mg BID + fosamprenavir/ritonavir 700/100 mg BID x 10 days
• Maraviroc
maraviroc 300 mg QD x 5 days
• Fosamprenavir/ritonavir
fosamprenavir/ritonavir 1400/100 mg QD x 10 days
• Maraviroc + Fosamprenavir/ritonavir
maraviroc 300 mg QD + fosamprenavir/ritonavir 1400/100 mg QD x 10 days

Locations

Country	Name	City	State
Singapore	Pfizer Investigational Site	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
ViiV Healthcare	Pfizer

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maraviroc plasma pharmacokinetic parameters: AUCt, Cmax, and Ct on Period 1, Day 5 and Period 2, Day 20		25 days	No
Primary	Amprenavir and ritonavir plasma pharmacokinetic parameters: AUCt, Cmax, and Ct on Period 2, Day 10 and Period 2, Day 20		25 days	No
Secondary	Maraviroc plasma pharmacokinetic parameter: Tmax on Period 1, Day 5 and Period 2, Day 20.		25 days	No
Secondary	Amprenavir and ritonavir plasma pharmacokinetic parameter: Tmax, on Period 2, Day 10 and Period 2, Day 20.		25 days	No
Secondary	Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments.		25 days	Yes

External Links

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