At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 25 enrolled
Drug / intervention
4 mg/kg +1 morebiological
Likely dose
4 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1 Study Evaluating The Pharmacokinetics And Pharmacodynamics Of Rn316 In Combination With Atorvastatin In Hypercholesterolemic Subjects
In Brief
A Phase 1 clinical trial evaluating 4 mg/kg and 0.5 mg/kg for Hypercholesterolemia and Dyslipidemia. Completed, enrolled 25 participants across 5 sites.
Detailed Summary
The primary objective of this study is to evaluate the pharmacokinetics and pharmacodynamics of a single dose of PF-04950615 (RN316) in volunteers on stable doses of atorvastatin. PF-04950615 (RN316) is an investigational drug that is currently being studies as a cholesterol lowering therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia, Dyslipidemia
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2010
First PostedJul 2010
Primary CompletionFeb 2011
Study CompletionApr 2011
TodayJul 2026
First PostedJul 16, 2010
Enrollment StartJul 1, 2010
Primary CompletionFeb 1, 2011
Study CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 16.0 years ago
Interventions
4 mg/kgbiological
RN316 10 mg/ml vial sd. Infusion based on weight Infusion duration = 60 minutes.
0.5 mg/kgbiological
RN316 10 mg/ml vial sd. Infusion based on weight Infusion duration = 60 minutes.