Drug-Drug Interaction Study With PF-05089771

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01934569
• Other study ID #: B3291023
• Status: Completed
• Phase: Phase 1
• First received: August 29, 2013
• Last updated: January 15, 2014
• Start date: September 2013
• Est. completion date: November 2013

Study information

• Verified date: January 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Pravastatin, 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

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax)		24h	No
Primary	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	No
Primary	Minimum Observed Plasma Trough Concentration (Cmin)		24h	No
Primary	Time to Reach Maximum Observed Plasma Concentration (Tmax)		24h	No
Secondary	Change from Baseline in Lipid Parameters	Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.	14 days	No

External Links

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