Drug-Drug Interaction Study With PF-05089771

NCT01934569 | Completed Phase 1

• 1 other identifier: B3291023
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Maximum Observed Plasma Concentration (Cmax)

  24h

• 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)

  24h

• Minimum Observed Plasma Trough Concentration (Cmin)

  24h

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

  24h

Secondary Outcomes (1)

• Change from Baseline in Lipid Parameters

  14 days

Study Arms (1)

Active tratment

EXPERIMENTAL

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

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

Interventions

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

Active tratment

Eligibility Criteria

• Age: 18 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 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);

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Brussels, B-1070, Belgium

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Pravastatin; Midazolam; Losartan; Omeprazole; Caffeine; PF-05089771

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Biphenyl Compounds; Benzene Derivatives; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Tetrazoles; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Benzimidazoles; Xanthines; Alkaloids; Purinones; Purines

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2013
• First Posted: September 4, 2013
• Study Start: September 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: January 16, 2014

Record last verified: 2014-01

Locations

BE (1)