A Study To Observe Safety And Concentrations Of PF-05297909 And Proteins In Both Blood And Cerebrospinal Fluid After A Single Dose Of PF-05297909 In Healthy Adults
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01462851
First received: September 8, 2011
Last updated: March 12, 2012
Last verified: March 2012
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Purpose
This study is designed to observe the safety and concentrations of PF-05297909 and proteins in both blood and cerebrospinal fluid after a single dose of PF-05297909 in healthy adults.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: PF-05297909 25 mg Drug: PF-05297909 100 mg Drug: PF-05297909 250 mg Drug: PF-05297909 525 mg |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
| Official Title: | A Phase 1, Randomized Investigator-And-Subject-Blind, Sponsor Open, Placebo Controlled Two-Part Study To Characterize The Pharmacokinetics And Pharmacodynamics Of Single Doses Of Pf-05297909 In Healthy Adult Subjects |
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Plasma area under the curve last (AUClast) pharmacokinetic parameter [ Time Frame: Day 1 to Day 3 ] [ Designated as safety issue: No ]
- Plasma apparent clearance (CL/F) pharmacokinetic parameter [ Time Frame: Day 0 to Day 3 ] [ Designated as safety issue: No ]
- Clinical potency of PF 05297909 for reduction in CSF levels of Abeta40, Abeta42, and/or AbetaX via estimation of the IC50 from a population PK/PD (PPK/PD) model [ Time Frame: Day 0 to Day 3 ] [ Designated as safety issue: No ]
- Plasma area under the curve infinity (AUCinf) pharmacokinetic parameter [ Time Frame: Day 1 to Day 3 ] [ Designated as safety issue: No ]
- Plasma half-life (t1/2) pharmacokinetic parameter [ Time Frame: Day 1 to Day 3 ] [ Designated as safety issue: No ]
- Plasma apparent volume of distribution (Vz/F) pharmacokinetic parameter [ Time Frame: Day 1 to Day 3 ] [ Designated as safety issue: No ]
- CSF concentration summary by time point for PF 05297909. [ Time Frame: Day 1 to Day 3 ] [ Designated as safety issue: No ]
- Change from baseline in CSF levels of Abeta40 [ Time Frame: Day 1 to Day 3 ] [ Designated as safety issue: No ]
- Change from baseline in CSF levels of Abeta42 [ Time Frame: Day 1 to Day 3 ] [ Designated as safety issue: No ]
- Change from baseline in CSF levels of AbetaX [ Time Frame: Day 1 to Day 3 ] [ Designated as safety issue: No ]
- Change from baseline in CSF levels of sAPPalpha [ Time Frame: Day 1 to Day 3 ] [ Designated as safety issue: No ]
- Change from baseline in CSF levels of sAPPbeta. [ Time Frame: Day 1 to Day 3 ] [ Designated as safety issue: No ]
| Enrollment: | 51 |
| Study Start Date: | September 2011 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Dose Escalation
Ascending doses in healthy volunteers
|
Drug: PF-05297909 25 mg
Single oral (PO) dose, PF-05297909 25 mg
Drug: PF-05297909 100 mg
Single oral (PO) dose, PF-05297909 100 mg
Drug: PF-05297909 250 mg
Single oral (PO) dose, PF-05297909 250 mg
Drug: PF-05297909 525 mg
Single oral (PO) dose, PF-05297909 525 mg
|
|
Experimental: Part 2: CSF PKPD
Pharmacokinetic and pharmacodynamic cerebrospinal fluid assessment
|
Drug: PF-05297909 525 mg
Single oral (PO) dose, 525 mg
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- For Healthy adult volunteers: healthy male and/or female subjects of non child bearing potential between the ages of 18 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 heart 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 time of dosing)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01462851
Locations
| United States, California | |
| Pfizer Investigational Site | |
| Glendale, California, United States, 91206 | |
| United States, Connecticut | |
| Pfizer Investigational Site | |
| New Haven, Connecticut, United States, 06511 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01462851 History of Changes |
| Other Study ID Numbers: | B3941001 |
| Study First Received: | September 8, 2011 |
| Last Updated: | March 12, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
healthy volunteer safety pharmacokinetic pharmacodynamic |
ClinicalTrials.gov processed this record on June 18, 2013