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CompletedNCT01056874Updated Apr 7, 2011

Effect Of Maraviroc On The Pharmacokinetics Of Digoxin

A Phase 1 interventional study of Digoxin and Digoxin in Healthy and HIV Infections, sponsored by ViiV Healthcare. Completed at 1 site in Singapore. Open to participants aged 21 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-04-07.

Sponsored by ViiV Healthcare · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
21 Years to 55 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Healthy
  • HIV Infections

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Keywords

  • Maraviroc
  • Digoxin
  • P-glycoprotein
  • Pharmacokinetics
  • Drug Interaction
  • HIV
03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 12 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

ViiV Healthcare is the lead sponsor of 261 studies on the registry; 16 are open to participants now.

Of its 66 completed or terminated interventional studies of FDA-regulated products, 50 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Active comparator
    Digoxin

    Drug: Digoxin

  • Experimental
    Digoxin + Maraviroc

    Drug: Digoxin · Drug: Maraviroc

Interventions

  • DrugDigoxin

    Oral Digoxin 0.25 mg single dose

  • DrugDigoxin

    Oral Digoxin 0.25 mg single dose on Day 5

  • DrugMaraviroc

    Oral Maraviroc 300 mg twice daily for 6 days

    Also known as: Selzentry, Celsentri

06

What researchers measure

Primary outcomes

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

    Time frame: 21 days

Secondary outcomes

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

    Time frame: 21 days

07

Study locations

1 site
  • Pfizer Investigational Site
    Singapore, 188770, Singapore
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01056874
Lead sponsor
ViiV Healthcare
Collaborators
Pfizer
First posted
Jan 26, 2010
Start date
Mar 2010
Primary completion
Apr 2010
Completion
Apr 2010
Last update
Apr 7, 2011

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.

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