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
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 April 16, 2014