NCT01243151|CompletedPhase 1Results

Safety And Tolerability Of Multiple Doses Of PF-04950615 (RN316) In Subjects With Hypercholesterolemia

A Phase 1, Placebo-controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Multiple Intravenous Doses Of Pf-04950615 In Healthy Adult Subjects With Hypercholesterolemia

Pfizer ClinicalTrials.gov

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1 other identifier

B1481009

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredNov 2010

StartedFeb 2011

CompletionOct 2011

Brief Summary

The primary objective of this study is to evaluate the safety and tolerability of repeated doses of PF-04950615 (RN316) in study volunteers with hypercholesterolemia. PF-04950615 is an investigational drug that is currently being studied as a lipid lowering agent.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started Feb 2011

Shorter than P25 for phase_1

Geographic Reach

1 country

9 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

8 months study duration

First Submitted

Initial submission to the registry

November 3, 2010

Completed

15 days until next milestone

First Posted

Study publicly available on registry

November 18, 2010

Completed

3 months until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed

7.3 years until next milestone

Results Posted

Study results publicly available

January 22, 2019

Completed

Last Updated

January 22, 2019

Status Verified

August 1, 2018

Enrollment Period

8 months

First QC Date

November 3, 2010

Results QC Date

September 8, 2017

Last Update Submit

August 8, 2018

Conditions

Hypercholesterolemia Dyslipidemia

Keywords

HypercholesterolemiaDyslipidemiaLDLHigh CholesterolJapanese VolunteersPF-04950615RN316

Outcome Measures

Primary Outcomes (7)

Number of Participants With Dose Limiting and Intolerable Treatment-Related Adverse Events (AEs)
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Dose limiting and intolerable treatment-related AEs were the AEs resulting from drug overdose, drug withdrawal, drug abuse, drug misuse, drug interactions, drug dependency, extravasation, exposure in utero, exposure during breast feeding.
Baseline up to Follow-up period (Day 78)
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Treatment-Related Adverse Events (AEs)
An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to Day 78 that were absent before treatment or that worsened relative to pretreatment state.
Baseline up to Follow-up period (Day 78)
Number of Participants With Adverse Events (AEs) by Severity
An AE was any untoward medical occurrence in a participant who received study drug. AE was assessed according to common terminology criteria for adverse events (CTCAE) version 4.0 severity grades- Grade 1: mild (asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2: moderate (minimal, local or non invasive intervention indicated); Grade 3: severe (medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling); Grade 4: Life-threatening consequences; urgent intervention indicated and Grade 5: Death related to AE.
Baseline up to Follow-up period (Day 78)
Number of Participants With Laboratory Test Abnormalities
Criteria: Haemoglobin(Hgb), hematocrit, RBC: \<0.8\*lower limit of normal(LLN),mean corpuscular volume, mean corpuscular Hgb concentration \<0.9\*LLN or\>1.1\*upper limit of normal(ULN), platelet\<0.5\*LLN or\>1.75\*ULN, WBC\<0.6\*LLN or\>1.5\*ULN, lymphocyte, neutrophil\<0.8\*LLN or\>1.2\*ULN, basophil, eosinophil, monocyte\>1.2\*ULN; bilirubin\>1.5\*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma glutamyl transferase, lactate dehydrogenase\>3.0\*ULN,total protein,albumin\<0.8\*LLN or\>1.2\*ULN; blood urea nitrogen, creatinine\>1.3\*ULN,uric acid\>1.2\*ULN;sodium\<0.95\*LLNor\>1.05\*ULN,potassium,chloride,calcium,bicarbonate\<0.9\*LLN or\>1.1\*ULN; glucose\<0.6\*LLN or \>1.5\*ULN, urine specific gravity\<1.003 or\>1.030,urine pH\<4.5or\>8,urine glucose, ketones, urine protein,urine blood/Hgb,urobilinogen,bilirubin,nitrite, leukocyte esterase\>=1; urine RBC,WBC\>=20,urine epithelial cells\>=6,urine granular casts,hyaline casts\>1,urine bacteria\>20,partial thromboplastin time,prothrombin:\>1.1\*ULN.
Baseline up to Follow-up period (Day 78)
Number of Participants With Clinically Relevant Changes in Vital Signs
Criteria for clinically relevant vital signs: supine and standing systolic blood pressure (SBP): less than (\<) 90 millimeter of mercury (mmHg); supine and standing diastolic blood pressure (DBP): \<50 mmHg. Maximum increase from baseline (IFB) or decrease from baseline (DFB) in supine and standing SBP: greater than or equal to (\>=) 30 mmHg and maximum IFB or DFB in supine and standing DBP: \>=20 mmHg. Supine pulse rate: \<40 and greater than (\>) 120 beats per minute (bpm); standing pulse rate: \<40 and \>140 bpm.
Baseline up to Follow-up period (Day 78)
Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Parameters
Criteria for clinically relevant ECG parameters: PR interval: maximum IFB of \>=25 percent or 50 percent; QRS complex: maximum IFB of \>=25 or 50 percent; QTcF interval (Fridericia's Correction): maximum IFB of \>=30 millisecond (msec) to \<60 msec and maximum IFB of \>=60 msec.
Baseline up to Follow-up period (Day 78)
Number of Participants With Anti-drug Antibodies (ADA)
The number of participants with at least one positive ADA were summarized for each treatment arm. Participants with positive antibody titer of \>4.32 milligram/milliliter (mg/mL) were considered as ADA positive.
Baseline up to Follow-up period (Day 78)

Secondary Outcomes (41)

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-04950615
Day 1 and 22: pre-dose and 1, 6, 9, 24 and 72 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615
Day 1 and 22: pre-dose and 1, 6, 9, 24 and 72 hours post dose
Maximum Observed Plasma Concentration (Cmax) of PF-04950615
Day 1 and 22: pre-dose and 1, 6, 9, 24 and 72 hours post dose
Plasma Decay Half-Life (t1/2) of PF-04950615
Day 1 and 22: pre-dose and 1, 6, 9, 24 and 72 hours post dose
Apparent Clearance (CL) of PF-04950615
Day 22: pre-dose and 1, 6, 9, 24 and 72 hours post dose
+36 more secondary outcomes