Effect Of Maraviroc On The Pharmacokinetics Of Digoxin

NCT01056874 | Completed Phase 1

• 1 other identifier: A4001097
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open labelled study to estimate the effect of maraviroc on the pharmacokinetics of digoxin, a probe for p-glycoprotein.

Conditions

Healthy; HIV Infections

Keywords

Maraviroc; Digoxin; P-glycoprotein; Pharmacokinetics; Drug Interaction; HIV

Outcome Measures

Primary Outcomes (1)

• To estimate the effect of multiple dose maraviroc on the pharmacokinetics of digoxin.

  21 days

Secondary Outcomes (1)

• To investigate the safety and tolerability of maraviroc and digoxin when co-administered.

  21 days

Study Arms (2)

Digoxin

ACTIVE COMPARATOR

Drug: Digoxin

Digoxin + Maraviroc

EXPERIMENTAL

Drug: Digoxin; Drug: Maraviroc

Interventions

Digoxin DRUG

Oral Digoxin 0.25 mg single dose

Digoxin

Maraviroc DRUG

Oral Maraviroc 300 mg twice daily for 6 days

Also known as: Selzentry, Celsentri

Digoxin + Maraviroc

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 25.5 kg/m2.
• Total body weight \>50 kg (110 lbs).

You may not qualify if:

• Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
• Subjects with an estimated creatinine clearance (CLcr) \<80 ml/min.
• Pregnant or nursing females.
• Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from at least 14 days prior to the first dose of study medication until completion of study.

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

HIV Infections

Interventions

Digoxin; Maraviroc

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic 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: January 22, 2010
• First Posted: January 26, 2010
• Study Start: March 1, 2010
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: April 7, 2011

Record last verified: 2011-04

Locations

SG (1)