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A Phase I Trial to Investigate the Safety and Tolerability of PF-06649751

Pfizer logo

Pfizer

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: PF-06649751

Study type

Interventional

Funder types

Industry

Identifiers

NCT01981694
B7601001

Details and patient eligibility

About

This study will determine the safety and tolerability of PF-06649751 given orally to healthy volunteers. To determine the optimal dose for future studies, the concentration of the drug over time will be determined by periodic blood samples. The rate of eye blinks will be measured as an indicator of PF-06649751 action on the receptors of interest in the brain.

Enrollment

18 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years
  • Female subjects of non childbearing potential that meet at least one of the following criteria: Achieved postmenopausal status, defined as: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle stimulating hormone (FSH) level confirming the postmenopausal status; Have undergone a documented hysterectomy and/or bilateral oophorectomy; Have medically confirmed ovarian failure.

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).
  • Any condition possibly affecting drug absorption.
  • Subjects with epilepsy, or history of epilepsy, or conditions that lower seizure threshold, seizures of any etiology (including substance or drug withdrawal), or who have increased risk of seizures as evidenced by history of EEG with epileptiform activity. Subjects with a history of childhood seizures, and history of head trauma with loss of consciousness requiring hospitalization overnight will be excluded as well.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

18 participants in 2 patient groups

Single ascending doses
Experimental group
Treatment:
Drug: PF-06649751
Drug: PF-06649751
Measurement of eye blink rate
Experimental group
Treatment:
Drug: PF-06649751
Drug: PF-06649751

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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