Safety and Tolerability Study of Multiple Doses of PF-06305591

Pfizer logo

Pfizer

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Placebo
Drug: PF-06305591

Study type

Interventional

Funder types

Industry

Identifiers

NCT01776619
B5281002

Details and patient eligibility

About

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.

Enrollment

43 patients

Sex

All

Ages

21 to 55 years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

43 participants in 5 patient groups

Multiple Dose: Cohort 1
Experimental group
Treatment:
Drug: PF-06305591
Drug: Placebo
Multiple Dose: Cohort 2
Experimental group
Treatment:
Drug: PF-06305591
Drug: Placebo
Multiple Dose: Cohort 3
Experimental group
Treatment:
Drug: PF-06305591
Drug: Placebo
Multiple Dose: Cohort 4
Experimental group
Treatment:
Drug: PF-06305591
Relative Bioavilability: Cohort 1
Experimental group
Treatment:
Drug: PF-06305591

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems