- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01959971
Effect of Alirocumab on Lipid Metabolism in Adults With Elevated LDL-Cholesterol
A Phase 1 Study of the Effects of Subcutaneous Doses of Alirocumab on Lipid and Lipoprotein Metabolism in Adults With Mildly Elevated LDL-Cholesterol
Primary Objective:
To assess the effects of subcutaneous (SC) doses of alirocumab on the elimination (measured by Fractional Clearance Rate (FCR)) of apolipoprotein B (apoB) in low density lipoprotein (LDL) in adults with mildly elevated LDL-cholesterol (LDL-C).
Secondary Objectives:
To assess the effects of SC doses of alirocumab on:
- Various parameters of the metabolism and turnover in plasma of different lipoproteins
- Plasma lipids concentration: total cholesterol, high density lipoprotein cholesterol (HDL-C), triglycerides, low density lipoprotein cholesterol (LDL-C), apoB, lipoprotein(a) (Lp(a))
- Lipoprotein particle size profile
- PCSK9 (free and total) concentrations in serum To assess safety and tolerability of alirocumab. To assess emergence of anti-alirocumab antibodies. To document serum alirocumab concentrations.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
New York
-
New York, New York, Forente stater, 10032
- Investigational Site Number 840001
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion criteria:
Generally healthy; LDL-C level in serum or plasma ≥ 100 mg/dL and < 190 mg/dL at Screening.
Exclusion criteria:
- LDL-C ≥ 160 mg/dL at Screening if more than 2 major Coronary Heart Disease risk factors, as defined in National Cholesterol Education Program guidelines.
- Receiving treatment of any kind for hyperlipidemia within 6 weeks of enrollment.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Placebo - Alirocumab
Injection through subcutaneous (SC) administration, placebo for 4 weeks then, alirocumab for 10 weeks
|
Pharmaceutical form:Solution for injection Route of administration: Subcutaneous
Andre navn:
Pharmaceutical form:Solution for injection Route of administration: Subcutaneous |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Percent change in Fractional Clearance Rate of apolipoprotein B (apoB) in Low Density Lipoproteins (pools/day) in plasma during alirocumab treatment
Tidsramme: baseline and at 12 days after last dose of alirocumab
|
baseline and at 12 days after last dose of alirocumab
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change in lipids turnover parameters measured in isolated Very Low Density Lipoproteins (VLDL), Intermediate Density Lipoproteins (IDL), Low Density Lipoproteins (LDL) and High Density Lipoproteins (HDL)
Tidsramme: baseline and at 12 days after last dose of alirocumab
|
baseline and at 12 days after last dose of alirocumab
|
Change in post-heparin hepatic lipase and lipoprotein lipase activities
Tidsramme: baseline and at 2 days after last dose of alirocumab
|
baseline and at 2 days after last dose of alirocumab
|
Change in lipids and apolipoproteins in plasma lipids panel
Tidsramme: baseline and at 2 days and at 11 days after last dose of alirocumab
|
baseline and at 2 days and at 11 days after last dose of alirocumab
|
Assessment of Lipoprotein particle size profiles
Tidsramme: baseline and at 2 days and at 11 days after last dose of alirocumab
|
baseline and at 2 days and at 11 days after last dose of alirocumab
|
Assessment of serum concentrations of PCSK9
Tidsramme: baseline and up to 2 weeks after last dose of alirocumab
|
baseline and up to 2 weeks after last dose of alirocumab
|
Assessment of safety parameters (clinical laboratory, ECG, vital signs)
Tidsramme: up to 10 weeks after last dose of alirocumab
|
up to 10 weeks after last dose of alirocumab
|
Assessment of the serum concentration of alirocumab
Tidsramme: baseline and up to 2 weeks after last dose of alirocumab
|
baseline and up to 2 weeks after last dose of alirocumab
|
Assessment of the serum concentration of anti-alirocumab antibodies
Tidsramme: baseline and up to 10 weeks after last dose of alirocumab
|
baseline and up to 10 weeks after last dose of alirocumab
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PDY13670
- U1111-1141-4567 (Annen identifikator: UTN)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
produkt produsert i og eksportert fra USA
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på alirocumab
-
Fundación Hipercolesterolemia FamiliarFullførtFamiliær hyperkolesterolemiSpania
-
Westside Medical Associates of Los AngelesRegeneron Pharmaceuticals; University of WashingtonUkjentAterosklerose | Høyt kolesterolForente stater
-
Population Health Research InstituteFullførtST Elevation Hjerteinfarkt | Dyslipidemier | Hyperkolesterolemi | Hyperlipidemier | Akutt koronarsyndrom | Fysiologiske effekter av legemidlerCanada
-
Shanghai Tong Ren HospitalChina Cardiovascular AssociationRekrutteringAkutt hjerteinfarktKina
-
Washington University School of MedicineFullført
-
Regeneron PharmaceuticalsSanofiFullførtHyperkolesterolemiForente stater, Bulgaria, Chile, Estland, Japan, Mexico, Den russiske føderasjonen, Sør-Afrika, Ukraina
-
University of VirginiaNorthwestern UniversityFullførtPerifer arteriell sykdomForente stater
-
Regeneron PharmaceuticalsSanofiAvsluttetHeterozygot familiær hyperkolesterolemi | Ikke-familiær hyperkolesterolemiForente stater, Bulgaria, Estland, Den russiske føderasjonen, Sør-Afrika, Ukraina
-
University Hospital Inselspital, BerneRegeneron PharmaceuticalsFullførtKoronar sirkulasjon | Atheroma; Myokard | KoronarkarDanmark, Sveits, Østerrike, Nederland
-
Regeneron PharmaceuticalsSanofiFullførtHeterozygot familiær hyperkolesterolemiForente stater, Tyskland