Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Multiple Dose Tolerance Study For PF-04958242

This study has been terminated.
(See termination reason in detailed description.)
Information provided by (Responsible Party):
Pfizer Identifier:
First received: November 2, 2010
Last updated: April 11, 2012
Last verified: April 2012
This study aims to assess the safety, tolerability, and pharmacokinetics of PF-04958242 at a number of ascending doses administered for 14 days in healthy volunteers.

Condition Intervention Phase
Drug: PF-04958242 0.03 mg
Drug: PF-04958242 0.05 mg
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase I, Randomized, Subject And Investigator-Blind, Sponsor Open, Multiple Escalating Dose Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of PF-04958242 In Healthy Adult Volunteers

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Composite of PF-04958242 Pharmacokinetics measured at 0.25, 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24 hours after dosing on Day 1 [ Time Frame: Day 1-2 ]
  • Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 4 [ Time Frame: Day 4 ]
  • Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 7 [ Time Frame: Day 7 ]
  • Composite of Pharmacokinetics measured at 0.25, 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24, 48, 72, 120 hours after dosing on Day 14 [ Time Frame: Day 14-18 ]
  • Composite of urine Pharmacokinetics measured for 24 hours post-dose on Day 14 [ Time Frame: Day 14-15 ]
  • Sheehan Suicidality Tracking Scale [ Time Frame: Days 0, 14, 24 ]

Secondary Outcome Measures:
  • Drug Liking Questionaire [ Time Frame: Day 14 ]
  • Digit symbol substitution test [ Time Frame: Days 0, 14 ]

Enrollment: 20
Study Start Date: November 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-04958242 Drug: PF-04958242 0.03 mg
0.03 mg dose tablet every 12 hours for 14 days
Drug: PF-04958242 0.05 mg
PF-04958242 0.05 mg dose tablet every 24 hours for 14 days
Placebo Comparator: Placebo Drug: Placebo
Placebo tablet every 12 hours or every 24 hours for 14 days

Detailed Description:
A decision was made to terminate the B1701002 study so that emerging data from the study and from a preclinical study in rats could be further examined and incorporated into a new study design and protocol.

Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • males or females of non-childbearing capacity

Exclusion Criteria:

  • No medical, neurological or psychiatric illness
  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 identifier: NCT01238679

Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer Identifier: NCT01238679     History of Changes
Other Study ID Numbers: B1701002
Study First Received: November 2, 2010
Last Updated: April 11, 2012

Keywords provided by Pfizer:
healthy volunteers processed this record on April 28, 2017