A Study To Evaluate The Safety, Tolerability And Plasma Drug Levels Of PF-04447943 When Administered With Donepezil To Healthy Volunteer Subjects

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01097876
First received: March 23, 2010
Last updated: August 3, 2010
Last verified: August 2010
  Purpose

The purpose of this study is to evaluate the safety and tolerability of PF-04447943, before and after multiple doses of donepezil in healthy volunteers. Evaluate the plasma drug levels of both PF-04447943 and donepezil.


Condition Intervention Phase
Healthy
Drug: PF-04447943 25 mg
Drug: Placebo PF
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Phase 1, Double-Blind, Placebo-Controlled, Sponsor Open, Randomized, Multiple Dose Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-04447943 In Healthy Volunteers When Combined With Donepezil

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Steady state PF 04447943 Cmax and AUCtau. [ Time Frame: up through day 44 ] [ Designated as safety issue: No ]
  • Steady state Donepezil Cmax and AUCtau. [ Time Frame: up through day 44 ] [ Designated as safety issue: No ]
  • Safety endpoints include vital signs, ECGs, clinical laboratory tests, clinical examinations, and adverse events. [ Time Frame: up through day 44 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • There are no Secondary Endpoints [ Time Frame: There are no Secondary Endpoints ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: April 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active PF-04447943 Drug: PF-04447943 25 mg
25 mg PF-04447943 BID for 7 days (period 1) 7 day washout (no drug) 7 days of 5 mg donepezil QD; 14 days 10 mg QD (Period 2) 7 days of 10 mg donepezil QD and 25 mg PF-04447943 BID (Period 3)
Placebo Comparator: Placebo PF-04447943 Drug: Placebo PF
Placebo BID for 7 days (period 1) 7 day washout (no drug) 7 days of 5 mg donepezil QD; 14 days 10 mg QD (Period 2) 7 days of 10 mg donepezil QD and Placebo BID (Period 3)

Detailed Description:

Evaluate the safety and tolerability of PF-04447943, before and after multiple doses of donepezil in healthy volunteers. Evaluate the plasma drug levels of both PF-04447943 and donepezil.

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and/or female of non-childbearing potential subjects 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 time of dosing).
  • Pregnant or nursing females; females of childbearing potential.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01097876

Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01097876     History of Changes
Other Study ID Numbers: B0401012
Study First Received: March 23, 2010
Last Updated: August 3, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
healthy volunteer
pharmacokinetic
safety

Additional relevant MeSH terms:
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014