PK following Intravenous Administration of PF-06427878
Research type
Research Study
Full title
A Phase 1, Non-Randomized, Open-Label, Single-Dose, Single Period Study with Non-Pharmacologically Active Dose of PF-06427878 to Characterize Pharmacokinetics Following Intravenous Administration in Healthy, Adult, Male Subjects
IRAS ID
163618
Contact name
Philip Evans
Contact email
Sponsor organisation
Pfizer Inc
Eudract number
2014-002626-12
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 0 months, 26 days
Research summary
The Sponsor is developing the study drug, PF-06427878, for the potential treatment of hyperlipidemia. Hyperlipidemia is a condition involving elevated levels of cholesterol and lipids (fats) in the bloodstream and can increase the risk of heart disease, stroke and other vascular diseases.
The study has been designed to look at how the study drug is taken up and removed by the body when given in a vein (intravenously, IV) to people. The study drug will be given as a non-pharmacologically (very tiny) active dose. A non-pharmacologically active dose is one which is not expected to affect the human body and therefore, no clinical benefit is expected. Although the study drug is being given as a very tiny dose, this is the first time that the study drug PF-06427878 will be administered to humans as an IV dose.
The study will consist of 1 study period involving up to 6 healthy male subjects. Each subject will receive 100 micrograms of the study drug, administered as a single IV infusion lasting 30 minutes.
REC name
Wales REC 1
REC reference
14/WA/1133
Date of REC Opinion
22 Oct 2014
REC opinion
Further Information Favourable Opinion