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Multiple Dose Tolerance Study For PF-04958242

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01238679
First received: November 2, 2010
Last updated: April 11, 2012
Last verified: April 2012
  Purpose

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
Healthy
Drug: PF-04958242 0.03 mg
Drug: PF-04958242 0.05 mg
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
  • Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 4 [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
  • Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 7 [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Composite of urine Pharmacokinetics measured for 24 hours post-dose on Day 14 [ Time Frame: Day 14-15 ] [ Designated as safety issue: No ]
  • Sheehan Suicidality Tracking Scale [ Time Frame: Days 0, 14, 24 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Drug Liking Questionaire [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
  • Digit symbol substitution test [ Time Frame: Days 0, 14 ] [ Designated as safety issue: No ]

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.

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01238679

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: Pfizer
ClinicalTrials.gov Identifier: NCT01238679     History of Changes
Other Study ID Numbers: B1701002
Study First Received: November 2, 2010
Last Updated: April 11, 2012
Health Authority: Singapore: Health Sciences Authority

Keywords provided by Pfizer:
safety
tolerability
pharmacokinetics
healthy volunteers

ClinicalTrials.gov processed this record on November 25, 2014