The Bioavailability of a Spray Dried Dispersion Solid Dose Formulation of PF-06260414 Relative to a Suspension Formulation
NCT02393807
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Healthy male and/or female subjects of non childbearing potential between the ages of 18 and 55 years, inclusive.
- 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)
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- New Haven, Connecticut
- Groningen,
- Utrecht,
- Paramus, New Jersey
- New Haven, Connecticut
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 |
| |||
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:
| |||
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 | 0 | |||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 |
| |||
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 |