Pharmacokinetics And Tolerability Of Subcutaneous Administration Of PF 04236921 In Healthy Volunteers
Phase I Pharmacokinetics And Tolerability Of PF-04236921 Following Subcutaneous Administration To Healthy Volunteers
2 other identifiers
interventional
10
1 country
1
Brief Summary
This study will evaluate the safety, tolerability, and pharmacokinetics of PF-04236921 administered as a single subcutaneous dose in healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started May 2010
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 11, 2010
CompletedFirst Posted
Study publicly available on registry
July 21, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedNovember 23, 2010
November 1, 2010
5 months
May 11, 2010
November 19, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Incidence and severity of adverse events
5 months
Incidence and severity of clinical findings on physical examination
5 months
Mean change from baseline in vital signs (blood pressure, pulse rate, oral or tympanic temperature) measurements
5 months
Mean change from baseline in 12-lead electrocardiogram (ECG) parameters: PRI, RR, QRS, QT, QTcF (Freidericia's correction) and HR (heart rate)
5 months
Serum PF-04236921 concentrations will be determined by a validated assay and noncompartmental PK parameters
5 months
Secondary Outcomes (2)
Incidence and severity of clinical laboratory abnormalities including absolute neturophil count, hepatic transaminases and bilirubin levels, and lipid profiles
5 months
Incidence and level of ADA development
5 months
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Healthy males between 18-55 years, inclusive.
- Healthy females of non-childbearing potential between 18 and 55 years, inclusive.
You may not qualify if:
- Evidence or history of clinically significant disease.
- Females of childbearing potential.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
Brussels, 1070, Belgium
Related Publications (1)
Li C, Shoji S, Beebe J. Pharmacokinetics and C-reactive protein modelling of anti-interleukin-6 antibody (PF-04236921) in healthy volunteers and patients with autoimmune disease. Br J Clin Pharmacol. 2018 Sep;84(9):2059-2074. doi: 10.1111/bcp.13641. Epub 2018 Jun 25.
PMID: 29776017DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 11, 2010
First Posted
July 21, 2010
Study Start
May 1, 2010
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
November 23, 2010
Record last verified: 2010-11