A Study to Assess the Relative Bioavailability of a Modified-Release Formulation of PF-05180999
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ClinicalTrials.gov Identifier: NCT01530529 |
Recruitment Status :
Completed
First Posted : February 10, 2012
Last Update Posted : May 1, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: PF-05180999 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | A Phase 1, Cross-Over, Single-Dose, Open-Label Study to Estimate the Relative Bioavailability of a Modified-Release Formulation of PF-05180999 Under Fed and Fasted Conditions in Healthy Adult Subjects |
Study Start Date : | January 2012 |
Actual Primary Completion Date : | April 2012 |
Actual Study Completion Date : | April 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: PF-05180999 Immediate-Release |
Drug: PF-05180999
Single dose of 30 mg of PF-05180999 administered to fasted subjects as an immediate-release powder-in-capsule formulation |
Experimental: PF-05180999 Modified-Release 1 |
Drug: PF-05180999
Single dose of 30 mg of PF-05180999 administered to fasted subjects as a modified-release formulation |
Experimental: PF-05180999 Modified-Release 2 |
Drug: PF-05180999
Single dose of 120 mg of PF-05180999 administered to fasted subjects as a modified-release formulation |
Experimental: PF-05180999 Modified-Release 1 With Food |
Drug: PF-05180999
Single dose of 30 mg of PF-05180999 administered to fed subjects as a modified-release formulation |
- Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period ]
- Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period ]
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period ]
- Plasma Decay Half-Life (t1/2) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period ]
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Male or female of non-childbearing potential
Exclusion Criteria:
- Evidence of clinically-significant medical illness, history of seizures, any condition possibly affecting drug absorption

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530529
United States, Connecticut | |
Pfizer Investigational Site | |
New Haven, Connecticut, United States, 06511 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT01530529 |
Other Study ID Numbers: |
B3441007 B3441007 |
First Posted: | February 10, 2012 Key Record Dates |
Last Update Posted: | May 1, 2012 |
Last Verified: | April 2012 |
PF-05180999 safety pharmacokinetics relative bioavailability |
Mental Disorders Schizophrenia and Disorders with Psychotic Features Schizophrenia |