Multiple Dose Escalation Trial Of PF-04308515 In Healthy Volunteers
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ClinicalTrials.gov Identifier: NCT01101932 |
Recruitment Status
:
Completed
First Posted
: April 12, 2010
Last Update Posted
: July 25, 2011
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Condition or disease | Intervention/treatment | Phase |
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Healthy | Drug: PF-04308515 Drug: Placebo Drug: PF-04308515 Tablet | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 58 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Basic Science |
Official Title: | A Phase 1, Placebo-Controlled, Multiple-Dose Escalation Trial Evaluating The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-04308515 (Part 1), And A Single Dose Pharmacokinetic Assessment Of A PF-04308515 Tablet Formulation (Part 2), In Healthy Volunteers |
Study Start Date : | March 2010 |
Actual Primary Completion Date : | November 2010 |
Actual Study Completion Date : | November 2010 |
Arm | Intervention/treatment |
---|---|
Experimental: (Part 1) PF-04308515 |
Drug: PF-04308515
PF-04308515 will be provided as an oral solution administered at doses of 3, 10, 30 and 100 mg. If an optional cohort is needed the dose would not exceed the established toxicokinetic exposure limits. Solution will be administered orally once daily for 14 days.
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Placebo Comparator: (Part 1) Solution Placebo |
Drug: Placebo
Placebo solution will be administered to those volunteers who are randomized to the placebo arm. Placebo solution will be administered orally once daily for 14 days.
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Experimental: (Part 2) PF-04308515 Tablet |
Drug: PF-04308515 Tablet
Tablet formulation to administer a 20 mg dose will be administered to volunteers in Part 2. The study medication will be administered orally once daily for 1 day.
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- Safety and tolerability of multiple doses of PF-04308515 as assessed by adverse event reporting, clinical laboratory results, vital signs, physical examinations and electrocardiograms (ECGs). [ Time Frame: 14 days ]
- Characterization of pharmacokinetic parameters of PF-04308515 after multiples doses which will include: Cmax, Tmax, AUC, CL/F, Vz/F, t1/2. Urinary excretion including AE% and CLr will be assessed at steady state. [ Time Frame: 14 days ]
- Change from baseline will be utilized to assess PF-04308515's pharmacodynamic effect on biochemical and metabolic biomarkers after 14 days of dosing. [ Time Frame: 14 days ]
- For the tablet pharmacokinetics:Cmax, Tmax, AUClast, AUCinf, CL/F, Vz/F, t1/2 will be calculated from the PF-04308515 plasma concentration versus time data. [ Time Frame: 1 day ]
- Safety and tolerability of 1 oral dose of a tablet formulation of PF-04308515 as assessed by adverse event reporting, clinical laboratory results, vital signs, physical examinations and electrocardiograms (ECGs). [ Time Frame: 1 day ]

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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:
- Healthy males between 18 and 55 years, inclusive
- Healthy females between 18 and 44 years, inclusive
- Females are required to be surgically sterile
Exclusion Criteria:
- Evidence or history of clinically significant disease
- Post-menopausal women
- History of intolerance or significant adverse effects with glucocorticoid therapy

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): NCT01101932
United States, Connecticut | |
Pfizer Investigational Site | |
New Haven, Connecticut, United States, 06511 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
ClinicalTrials.gov Identifier: | NCT01101932 History of Changes |
Other Study ID Numbers: |
B0861002 |
First Posted: | April 12, 2010 Key Record Dates |
Last Update Posted: | July 25, 2011 |
Last Verified: | July 2011 |
Keywords provided by Pfizer:
Safety Tolerability Pharmacokinetics/Pharmacodynamics Rheumatoid Arthritis healthy volunteers |