A Study to Evaluate the Pharmacodynamic Effects of Single Oral Doses of PF-06648671 on β-Amyloid (Aβ) Concentrations in Cerebrospinal Fluid (CSF)
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | October 2015 |
| End Date: | March 2016 |
A Phase 1 Investigator-and-subject Blind, Randomized, Placebo Controlled, Parallel Study In Healthy Subjects To Evaluate The Pharmacodynamic Effects Of Single Oral Doses Of Pf-06648671 On Aβ Concentrations In Cerebrospinal Fluid Using Serial Sampling Methodology
This is phase 1 investigator-and-subject blind, sponsor open, randomized, placebo
controlled, parallel study in healthy subjects to evaluate the pharmacodynamics effect of
single oral doses of PF-06648671 on CSF Aβ concentrations using serial CSF sampling
methodology.
controlled, parallel study in healthy subjects to evaluate the pharmacodynamics effect of
single oral doses of PF-06648671 on CSF Aβ concentrations using serial CSF sampling
methodology.
This study is investigator-and-subject blind, sponsor open, randomized, placebo-controlled,
parallel study in healthy subjects to evaluate central (CSF) and peripheral (plasma)
pharmacodynamics effects (Abeta) over 36 hours post single doses of PF-06648671. Two cohorts
will be run in sequential. the first cohort is to evaluate the Abeta effect at top dose of
300 mg PF-06648671 and second cohort is to evaluate the Abeta effect at top dose (if more
subjects are required) and/or 1-2 lower doses
parallel study in healthy subjects to evaluate central (CSF) and peripheral (plasma)
pharmacodynamics effects (Abeta) over 36 hours post single doses of PF-06648671. Two cohorts
will be run in sequential. the first cohort is to evaluate the Abeta effect at top dose of
300 mg PF-06648671 and second cohort is to evaluate the Abeta effect at top dose (if more
subjects are required) and/or 1-2 lower doses
Inclusion Criteria:
- Healthy male and/or female subjects of non childbearing potential
- BMI of 17.5 to 30.5 kg/m2 and a total body weight >50 kg (110 lbs)
- Evidence of a personally signed and dated informed consent document indicating that
subject has been informed of all pertinent aspects of the study.
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)
- Treatment with an investigational drug within 30 days (or as determined by the local
requirement) or 5 half-lives preceding the first dose of study medication (whichever
is longer)
- Subjects with a history of significant active bleeding, coagulation disorder or
clinically significant finding on prothrombin time/ partial thromboplastin
time/International Normalized Ratio (PT/PTT/INR) at Screening
- Subjects with lower spinal malformations (on physical examination), local spinal
infection, or other abnormalities that would exclude puncture (LP)
- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the subject
inappropriate for entry into this study
We found this trial at
2
sites
Click here to add this to my saved trials
Click here to add this to my saved trials