Multiple Dose Escalation Trial Of PF-04308515 In Healthy Volunteers
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01101932
First received: March 11, 2010
Last updated: July 21, 2011
Last verified: July 2011
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Purpose
The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics (how the drug effects certain target sites of activity in the body) of escalating doses of oral PF-04308515 in healthy volunteers for 14 days as well as one oral dose of a tablet formulation administered for 1 day.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: PF-04308515 Drug: Placebo Drug: PF-04308515 Tablet |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 58 |
| Study Start Date: | March 2010 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
| 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.
|
| 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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01101932
Please refer to this study by its ClinicalTrials.gov identifier: NCT01101932
Locations
| United States, Connecticut | |
| Pfizer Investigational Site | |
| New Haven, Connecticut, United States, 06511 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT01101932 History of Changes |
| Other Study ID Numbers: | B0861002 |
| Study First Received: | March 11, 2010 |
| Last Updated: | July 21, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Safety Tolerability Pharmacokinetics/Pharmacodynamics Rheumatoid Arthritis healthy volunteers |
ClinicalTrials.gov processed this record on March 03, 2015