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

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00991016

Enrollment

Registered

2009-10-07

Start date

2009-10-31

Completion date

2010-08-31

Last updated

2010-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Brief summary

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

Interventions

DRUGPF-04805712

ascending single and multiple doses starting at 30 mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

21 Years to 55 Years

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Pharmacodynamics: Urinary LTE4	12 weeks

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026