- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00803894
A Clinical Study to Determine Biomarkers of Response to a Gamma Secretase Inhibitor
16. juni 2016 opdateret af: Merck Sharp & Dohme LLC
A Randomized Clinical Trial to Study the Effects of MK0752 Versus Placebo on Biomarkers in Healthy Young Adult Male Subjects
The purpose of this study is to determine the transcriptional signature of Notch Inhibition by testing hair and blood samples on healthy male volunteers who have received MK0752 vs placebo for possible future biomarkers in the treatment of cancer or Alzheimers Disease
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
30
Fase
- Fase 1
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 35 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Han
Beskrivelse
Inclusion Criteria:
- Patient is a male
- Patient has no clinically significant abnormality on electrocardiogram performed
- Patient agrees to not to consume apple juice, grapefruit or grapefruit products beginning 2 weeks prior to first dose of study drug and for the duration of the study
- Patient has been a nonsmoker and/or has not used nicotine or nicotine-containing products for approximately 6 months.
- Patient is willing to not use any hair enhancement product or procedures for the duration of the study (for example, permanents, hair straightening techniques)
- Patient has a full head of hair
- Patient has at least 90% non-gray hair
Exclusion Criteria:
- Patient has had treatment with any investigational therapy during the prior 21 days
- Patient has any history of significant gastrointestinal abnormalities within the last 10 years
- Patient has a history of any long-term or active liver disease including elevated liver blood tests. Any patient with a history of Hepatitis B or C (and/or treated previously) will be excluded
- Patient has a known history or family history of aortic valve disease, congenital (from birth) heart disease or deafness, hearing loss or early onset Alzheimer's disease (onset at age < 55)
- Patient has a known sensitivity to the ingredients in the drug
- Patient has had active and uncontrolled infection within the past month
- Patient is HIV positive
- Patient has a history of stomach, intestine, heart, blood, liver, brain, kidney, lung, bladder or endocrine abnormalities or diseases
- Patient has a history of cancer except for certain skin cancer (basal cell)
- Patient has a history of multiple and/or severe allergies or has had an allergic reaction to food or prescription/non-prescription drugs
- Patient has had major surgery, donated or lost 1 unit of blood (about 500 mL) within the past month
- Patient has premature graying hair (> 10% gray hair)
- Patient has male pattern hair loss
- Patient has a prior history of high blood pressure
- Patient uses any medication, including prescription and non-prescription drugs or herbal remedies (such as St. John's Wort) beginning approximately 2 weeks prior to the first dose of study drug, throughout the study until the post study visit
- Patient consumes excessive amounts of alcohol (greater than 3 glasses of alcoholic beverages)
- Patient consumes excessive amounts (greater than 6 servings) of coffee, tea, cola or other caffeinated beverages per day
- Patient is a regular use (including "recreational use") of any illicit drugs, has a positive urine drug screen before randomization or has a history of drug (including alcohol) abuse within approximately the past 2 years
- Patient has prior exposure to MK 0752 with the past 21 days
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: C
Placebo
|
Single dose placebo capsules: there will be a 7-day washout period between treatments.
|
|
Aktiv komparator: A
MK0752 1000 mg
|
Single dose MK0752 capsules, 1000 mg: there will be a 7-day washout period between treatments.
|
|
Aktiv komparator: B
MK0752 350 mg
|
Single dose MK0752 capsules, 350 mg: there will be a 7-day washout period between treatments.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
To evaluate the existing Notch response signature using plucked hair follicle profiling data from health young male volunteers given 1000 mg MK0752 and 350 mg MK0752.
Tidsramme: 8.5 hours post dose.
|
8.5 hours post dose.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. december 2008
Primær færdiggørelse (Faktiske)
1. januar 2009
Studieafslutning (Faktiske)
1. januar 2009
Datoer for studieregistrering
Først indsendt
5. december 2008
Først indsendt, der opfyldte QC-kriterier
5. december 2008
Først opslået (Skøn)
8. december 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
17. juni 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. juni 2016
Sidst verificeret
1. juni 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 0752-022
- 2008_594
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .