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First-In-Human Study Of PF-04958242 In Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01159483
First received: July 7, 2010
Last updated: October 25, 2010
Last verified: October 2010
  Purpose

PF-04958242 in single doses will be safe and well tolerated by healthy volunteers.


Condition Intervention Phase
Healthy
Drug: PF-04958242
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Phase I, First-In-Human, Randomized, Subject And Investigator-Blind, Sponsor Open, Single 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:
  • Safety endpoints including physical examinations, neurological examinations, adverse events, clinical laboratory measurements including CK, vital signs and ECGs. [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
  • Non-compartment plasma pharmacokinetic parameter endpoints include Cmax, Tmax, AUC0-last, AUC0-∞, and when appropriate CL/F, Vz/F and t1/2. [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Urinary pharmacokinetic parameter endpoints include Ae, Ae%, and CLr. [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • DEQ drug-liking/disliking data and DSST psychomotor performance data. [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: August 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1 Drug: PF-04958242
oral PIB, single dose, 0.01 mg, 0.03 mg, 0.1 mg
Experimental: Cohort 2 Drug: PF-04958242

oral PIB, single dose, 0.3 mg, 0.6 mg*, 1.0 mg*

*Unlikely to be administered as expected to exceed exposure limits.


Detailed Description:

To test the safety, tolerability and pharmacokinetics of PF-04958242 in healthy volunteers.

  Eligibility

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

Inclusion Criteria:

  • healthy volunteers, male and female, ages 21-55

Exclusion Criteria:

  • No women of child-bearing potential, no risk factors for seizures, no risk factors for QTc prolongation
  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: NCT01159483

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: NCT01159483     History of Changes
Other Study ID Numbers: B1701001
Study First Received: July 7, 2010
Last Updated: October 25, 2010
Health Authority: Singapore: Institutional Review Board

Keywords provided by Pfizer:
safety
tolerability
pharmacokinetics

ClinicalTrials.gov processed this record on November 24, 2014