A Comparison Of The Pharmacokinetics Of PF-04191834 Following Single Dose Administration Of A Dispersion Formulation And A Suspension Formulation In Healthy Volunteers
This study has been withdrawn prior to enrollment.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01265732
First received: November 30, 2010
Last updated: February 16, 2011
Last verified: February 2011
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Purpose
This study investigates the safety, tolerability and pharmacokinetics of PF-04191834 when respectively given orally as a single dispersion dose and a single dose of a suspension. The suspension is the test formulation and the dispersion is the formulation with which the novel preparation will be compared.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: PF-04191834 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | An Open Label, Randomized 3-Way Crossover Single Dose Study To Compare The Pharmacokinetics And Relative Bioavailability Of PF-04191834 Using An Oral Wet-Milled Suspension Formulation Versus An Oral Single Dose Dispersion Formulation Under Fasted Conditions In Healthy Volunteers |
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Time of maximum concentration(Tmax) of PF-04191834 in plasma. [ Time Frame: 3 days ] [ Designated as safety issue: No ]
- Area under the curve (AUClast) from the time of dosing to the last data point taken for PF-04191834. [ Time Frame: 3 days ] [ Designated as safety issue: No ]
- Area under the curve from the time of dosing extrapolated to infinity(AUCinf) of PF-04191834. [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Maximum concentration (Cmax) for PF-04191834 in plasma. [ Time Frame: 3 days ] [ Designated as safety issue: No ]
- Elimination half-life (t1/2) of PF-05089771 [ Time Frame: 3 days ] [ Designated as safety issue: No ]
- Sheehan suicidality tracking scale (SSTS) [ Time Frame: Screening and last Day of Period 3 ] [ Designated as safety issue: Yes ]
- Number of adverse events in patients as a measure of safety and tolerability. [ Time Frame: Throughout the study. ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 12 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | January 2011 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: oral single dose dispersion 100mg
Subjects receive a single dose of PF-04191834 as a dispersion
|
Drug: PF-04191834
single dose, 100mg, dispersion
|
|
Active Comparator: oral wet milled suspension 100mg
Subjects receive a single dose of PF-04191834 as a suspension
|
Drug: PF-04191834
single dose, 100mg, suspension
|
|
Active Comparator: oral wet milled suspension 300mg
Subjects receive a single dose of PF-04191834 as a suspension
|
Drug: PF-04191834
single dose, 300mg, suspension
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG or clinical laboratory tests.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg(110 lbs).
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Clinical evidence of existing hepatic disease or a medical history of such a condition in the last year. Subjects with AST or ALT >ULN. Subjects with total bilirubin >ULN (except those with a documented history of Gilbert's Syndrome). Subjects with AST/ALT/total bilirubin >ULN and <1.5X ULN may be retested once.
- Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication;
- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day;
- Females of childbearing potential.
- Subjects with positive responses (score 1) for suicidality on the Sheehan Suicidality Tracking Scale (S-STS) (specifically items 1a, 1b, 3, 4, 5, 6, 7, or 9).
Contacts and Locations
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT01265732 History of Changes |
| Other Study ID Numbers: | B0041012 |
| Study First Received: | November 30, 2010 |
| Last Updated: | February 16, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Phase 1 relative bioavailability healthy volunteers |
pharmacokinetics suspension dispersion |
ClinicalTrials.gov processed this record on May 19, 2013