Single and Multiple Dose Safety, Tolerability, and Pharmacokinetics Study of PF-04805712 in Healthy Volunteers

Phase 1

Terminated

• Conditions: Healthy Volunteers
• Interventions: Drug: PF-04805712

• Registration Number: NCT00991016
• Lead Sponsor: Pfizer

Brief Summary

To assess the safety and tolerability of escalating single and multiple doses of the compound in healthy volunteers

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-05
• Study First Submitted QC: 2009-10-05
• Study First Posted: 2009-10-07
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-23
• Last Update Posted: 2010-11-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• Healthy males and females of non-childbearing potential.

Exclusion Criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PF-04805712	PF-04805712	-

Primary Outcome Measures

Name	Time	Method
Safety: Adverse events, vital signs measurements, telemetry, 12 lead ECGs, blood and urine safety tests.	12 weeks
Pharmacokinetics: PK parameters will be determined after single dose, fasted and (at one dose) fed, and at steady state (fasted or fed depending on single dose data).	12 weeks

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamics: Urinary LTE4	12 weeks

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇬 Singapore, Singapore