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NCT00991016 Clinical Trial

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

Healthy Volunteers Clinical Trial

Official title:
A Phase 1 Randomized, Double Blind (3rd Party Open), Placebo Controlled Combined Single And Multiple Dose Safety, Tolerability And Pharmacokinetics Study Of Orally Administered PF-04805712 In Healthy Volunteers

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00991016
Other study ID # B1411001
Secondary ID
Status Terminated
Phase Phase 1
First received October 5, 2009
Last updated November 23, 2010
Start date October 2009
Est. completion date August 2010

Study information
Verified date November 2010
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Singapore: Health Authority and EC
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Terminated
Enrollment 61
Est. completion date August 2010
Est. primary completion date August 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years to 55 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• PF-04805712
ascending single and multiple doses starting at 30 mg

Locations
Country Name City State
Singapore Pfizer Investigational Site Singapore

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Singapore, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety: Adverse events, vital signs measurements, telemetry, 12 lead ECGs, blood and urine safety tests. 12 weeks Yes
Primary 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 No
Secondary Pharmacodynamics: Urinary LTE4 12 weeks No
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