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CompletedNCT01934569Updated Jan 16, 2014

Drug-Drug Interaction Study With PF-05089771

A Phase 1 interventional study of Pravastatin, midazolam, losartan, omeprazole, caffeine and PF-05089771 in Healthy, sponsored by Pfizer. Completed at 1 site in Belgium. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-01-16.

Sponsored by Pfizer · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
17
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study summary

This study will test the potential for PF-05089771 to interact with a cocktail of drugs

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

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

04

Who can participate

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

Inclusion criteria

  • Healthy male and/or female subjects between the ages of 18 and 55 years;
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs);

Exclusion criteria

Exclusion Criteria:

  • Any condition possibly affecting drug absorption
  • History of regular alcohol consumption
  • Screening supine blood pressure >140 mm Hg (systolic) or >90 mm Hg (diastolic),
  • Consumption of coffee, cola or other caffeine containing drinks
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    Active tratment

    Pravastatin, midazolam, losartan, omeprazole, caffeine single dose alone or in combination with PF-05089771

    Drug: Pravastatin, midazolam, losartan, omeprazole, caffeine and PF-05089771

Interventions

  • DrugPravastatin, midazolam, losartan, omeprazole, caffeine and PF-05089771

    PF-05089771 450mg single dose and titration from 150mg BID to 450mg BID Pravastatin 10mg dingle dose, Midazolam 7.5mg single dose, Losartan 25mg single dose, Caffeine 100mg single dose, Omeprazole 20mg single dose

06

What researchers measure

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 24h

  2. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

    Time frame: 24h

  3. Minimum Observed Plasma Trough Concentration (Cmin)

    Time frame: 24h

  4. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: 24h

Secondary outcomes

  1. Change from Baseline in Lipid Parameters

    Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.

    Time frame: 14 days

07

Study locations

1 site
  • Pfizer Investigational Site
    Brussels, B-1070, Belgium
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01934569
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Sep 4, 2013
Start date
Sep 2013
Primary completion
Nov 2013
Completion
Nov 2013
Last update
Jan 16, 2014

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 Jan 2014. You cannot join it, but the record below documents what was studied.

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