Safety and Tolerability Study of Multiple Doses of PF-06305591
This study is not yet open for participant recruitment.
Verified April 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01776619
First received: January 23, 2013
Last updated: April 25, 2013
Last verified: April 2013
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Purpose
Safety, tolerability and PK of repeated doses of PF-06305591 will be evaluated in young healthy volunteers toghether with food effect on relative bioavailability of solid formulation after single dose.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: PF-06305591 Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
| Official Title: | A Double Blind (3rd Party Open) Randomized, Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics of Repeat Doses PF-06305591 Combined With a Cross-over Relative Bioavailability and Food Effect Evaluation After Single Dose of PF-06305591 in Healthy Young Subjects |
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
- Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- Area under the Concentration-Time Curve (AUC) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- Area Under the Curve from Time Zero to end of dosing interval (AUCtau) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 52 |
| Study Start Date: | April 2013 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Multiple Dose: Cohort 1 |
Drug: PF-06305591
14 day repeated BID doses
Drug: Placebo
14 day repeated BID doses
|
| Experimental: Multiple Dose: Cohort 2 |
Drug: PF-06305591
14 day repeated BID doses
Drug: Placebo
14 day repeated BID doses
|
| Experimental: Multiple Dose: Cohort 3 |
Drug: PF-06305591
14 day repeated BID doses
Drug: Placebo
14 day repeated BID doses
|
| Experimental: Multiple Dose: Cohort 4 |
Drug: PF-06305591
14 day repeated BID doses
|
| Experimental: Relative Bioavilability: Cohort 1 |
Drug: PF-06305591
relative bioavailability tablet vs. solution and food effect
|
Eligibility| Ages Eligible for Study: | 21 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy male or female subjects of non childbearing potential, between the ages of 21 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 and clinical laboratory tests
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).
- Any condition possibly affecting drug absorption (eg, gastrectomy).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01776619
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Locations
| Belgium | |
| Pfizer Investigational Site | Recruiting |
| Brussels, Belgium, B-1070 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01776619 History of Changes |
| Other Study ID Numbers: | B5281002 |
| Study First Received: | January 23, 2013 |
| Last Updated: | April 25, 2013 |
| Health Authority: | Belgium : Commission d'Ethique Biomédicale Hospitalo-Facultaire |
Keywords provided by Pfizer:
|
Safety tolerability PK |
ClinicalTrials.gov processed this record on May 19, 2013