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Multiple Dose Tolerance Study For PF-04958242

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ClinicalTrials.gov Identifier: NCT01238679
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : November 10, 2010
Last Update Posted : April 13, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: PF-04958242 0.03 mg Drug: PF-04958242 0.05 mg Drug: Placebo Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : November 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]
  2. Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 4 [ Time Frame: Day 4 ]
  3. Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 7 [ Time Frame: Day 7 ]
  4. 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 ]
  5. Composite of urine Pharmacokinetics measured for 24 hours post-dose on Day 14 [ Time Frame: Day 14-15 ]
  6. Sheehan Suicidality Tracking Scale [ Time Frame: Days 0, 14, 24 ]

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


Information from the National Library of Medicine

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

Inclusion Criteria:

  • males or females of non-childbearing capacity

Exclusion Criteria:

  • No medical, neurological or psychiatric illness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01238679


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

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01238679     History of Changes
Other Study ID Numbers: B1701002
First Posted: November 10, 2010    Key Record Dates
Last Update Posted: April 13, 2012
Last Verified: April 2012

Keywords provided by Pfizer:
safety
tolerability
pharmacokinetics
healthy volunteers