Study to Investigate the Safety, Tolerability, Pharmacokinetics of PF-06305591 in Healthy Male and Female Subjects

A Double Blind (3rd Party Open) Randomized, Placebo Controlled, Crossover Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics of PF-06305591 in Healthy Male and Female Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01747941

Enrollment

Registered

2012-12-12

Start date

2012-11-30

Completion date

2013-05-31

Last updated

2013-05-23

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

Conditions

Healthy

Brief summary

The study is designed to test safety tolerability and PK of single oral ascending doses of PF-06305591,

Interventions

DRUGPF-06305591

single dose, solution

DRUGPlacebo

matching placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* healthy young subjects * aged 18-55

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 the time of dosing). * Pregnant or nursing females; females of childbearing potential.

Design outcomes

Primary

Measure	Time frame
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	72 hr

Secondary

Measure	Time frame
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]	72 hr

Countries

Belgium

Outcome results

None listed

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