Safety and Tolerability Study of Multiple Doses of PF-06305591

A Double Blind (3rd Party Open) Randomized, Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics of Repeat Doses PF-06305591 Combined With a Cross-over Relative Bioavailability and Food Effect Evaluation After Single Dose of PF-06305591 in Healthy Young Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01776619

Enrollment

Registered

2013-01-28

Start date

2013-04-30

Completion date

2013-11-30

Last updated

2013-12-03

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

Conditions

Healthy

Keywords

Safety, tolerability, PK

Brief summary

Safety, tolerability and PK of repeated doses of PF-06305591 will be evaluated in young healthy volunteers toghether with food effect on relative bioavailability of solid formulation after single dose.

Interventions

DRUGPlacebo

14 day repeated BID doses

DRUGPF-06305591

14 day repeated 20mg BID doses

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

21 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male or female subjects of non childbearing potential, between the ages of 21 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests

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). * Any condition possibly affecting drug absorption (eg, gastrectomy).

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	14 days	Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to \[study drug\] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Maximum Observed Plasma Concentration (Cmax)	14 days	—
Area under the Concentration-Time Curve (AUC)	14 days	AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)	14 days	AUC is a measure of the serum concentration of the drug over time interval. It is used to characterize drug absorption.

Countries

Belgium

Outcome results

None listed

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