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Trial record 1 of 1 for:    NCT02393807
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The Bioavailability of a Spray Dried Dispersion Solid Dose Formulation of PF-06260414 Relative to a Suspension Formulation

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ClinicalTrials.gov Identifier: NCT02393807
Recruitment Status : Withdrawn
First Posted : March 19, 2015
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE March 9, 2015
First Posted Date  ICMJE March 19, 2015
Last Update Posted Date November 14, 2018
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2015)
  • Single dose pharmacokinetics under fasted condition: Cmax of PF- 06260414 formulations [ Time Frame: Hour 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose ]
  • Single dose pharmacokinetics under fasted condition: AUClast of PF- 06260414 formulations [ Time Frame: Hour 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose ]
  • Single dose pharmacokinetics under fed condition: Cmax of PF- 06260414 formulations [ Time Frame: Hour 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose ]
  • Single dose pharmacokinetics under fed condition: AUClast of PF- 06260414 formulations [ Time Frame: Hour 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02393807 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2015)
  • AUCinf of PF-06260414 [ Time Frame: Hour 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose ]
  • t½ of PF-06260414 [ Time Frame: Hour 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose ]
  • Tmax of PF-06260414 [ Time Frame: Hour 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Bioavailability of a Spray Dried Dispersion Solid Dose Formulation of PF-06260414 Relative to a Suspension Formulation
Official Title  ICMJE A Phase 1 Single-dose Open Label 3-way Crossover Study To Evaluate The Bioavailability Of A Spray Dried Dispersion Solid Dose Formulation Of Pf-06260414 Relative To A Suspension Formulation Under Fasted Conditions And The Effect Of Food On The Bioavailability Of The Pf-06260414 Spray Dried Dispersion Solid Formulation In Healthy Subjects
Brief Summary The current study will investigate the relative bioavailability of a spray dried dispersion solid dose formulation of PF 06260414 administered as a single oral dose of 30 mg of PF 06260414 relative to a single oral dose of 30 mg of PF 06260414 administered as a nanosuspension under fasted or fed conditions in healthy adult subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: PF 06260414 solid dose formulation
    Single dose of 30 mg PF-06260414 given under fed/fasted conditions
  • Drug: PF-06260414 nanosuspension
    Single dose of 30 mg PF-06260414 given under fasted conditions
Study Arms  ICMJE Experimental: Open label single dose crossover study of PF-06260414
This will be a Phase 1, open label, randomized, single dose, 3 period, 3 way crossover study to evaluate the relative bioavailability of solid dose formulation of PF 06260414 under fasted conditions compared to the nanosuspension under fasted conditions
Interventions:
  • Drug: PF 06260414 solid dose formulation
  • Drug: PF-06260414 nanosuspension
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 27, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: March 13, 2015)
12
Estimated Study Completion Date  ICMJE July 2015
Estimated Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female subjects of non childbearing potential between the ages of 18 and 55 years, inclusive.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
  • Any condition possibly affecting drug absorption (eg, gastrectomy)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02393807
Other Study ID Numbers  ICMJE B7411002
SARM FOOD EFFECT & BE ( Other Identifier: Alias Study Number )
SARM FOOD EFFECT &BE ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP