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Completed

NCT Number: NCT01934569

Drug-Drug Interaction Study With PF-05089771

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

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Brussels, B-1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

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

Drug

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

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 24h

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

    Time frame: 24h

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

  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

    Time frame: 14 days

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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Evaluation Of The Effect Of PF-05089771 On The Metabolism Of Multiple Cytochrome P450 And OATP1B1 Transporter Substrates

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Sep 4, 2013
Registry last updated
Jan 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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