A Phase I Trial to Investigate the Safety and Tolerability of PF-06649751
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 3/1/2014 |
| Start Date: | November 2013 |
| End Date: | February 2014 |
| Contact: | Pfizer CT.gov Call Center |
| Phone: | 1-800-718-1021 |
A Phase 1, Double Blind, Sponsor Open, Randomized, Placebo Controlled, Crossover, Single Oral Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06649751 in Healthy Subjects
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.
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.
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.
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