NCT01247896

Single Dose Escalation Study of PF-05190457 in Healthy Volunteers

A Phase 1 Placebo-controlled Trial to Assess the Safety, Tolerability, and Pharmacokinetics of Single Escalating Oral Doses of PF-05190457 Under Fasted and Fed Conditions in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

PF-05190457 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The purpose of the study is to evaluate the safety and tolerability of PF-05190457 after administration of a single dose to healthy volunteers and to evaluate the plasma drug concentrations after single dose in healthy volunteers.

Conditions

• Diabetes Mellitus, Type II

Interventions

Type	Name	Description
DRUG	PF-05190457	Single Dose 2 mg
DRUG	PF-05190457	Single Dose 10 mg
DRUG	PF-05190457	Single Dose 30 mg
DRUG	PF-05190457	Single Dose 100 mg
DRUG	PF-05190457	Single Dose 300 mg
DRUG	PF-05190457	Single Dose 600 mg
DRUG	PF-05190457	Single Dose - to be determined with food
DRUG	PF-05190457	Single Dose - to be determined
DRUG	Placebo	Single Dose Placebo

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2010-11-24
• Last updated: 2011-07-06

Locations

1 site across 1 country: Belgium