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A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP015K

30. juni 2011 opdateret af: Astellas Pharma Inc

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP015K Following Single Oral Doses to Healthy Volunteers

The objective of the study is to explore safety and tolerability of single ascending doses of ASP015K, establish the maximum tolerated dose, and determine the pharmacokinetics and pharmacodynamics in healthy volunteers.

Studieoversigt

Status

Afsluttet

Intervention / Behandling

Detaljeret beskrivelse

Subjects will be confined to the clinical research unit for five days. Some subjects will participate in two confinement periods. Subjects will receive a follow-up phone call to assess safety seven days after the administration of the single dose of study drug.

Subjects will be assigned to one of nine sequential groups A, B, C, D, E, F, G, H, or I. In each group, 6 subjects will be randomized to ASP015K and 2 subjects will be randomized to placebo. Subjects in group F will participate in two treatment periods. Subjects in the first treatment period of group F will have a single study drug dose administered in the fasted state. Subjects in the second treatment period of group F will have a single study drug dose administered immediately following a standard FDA recommended high-fat breakfast.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

72

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Florida
      • Miami, Florida, Forenede Stater, 33014
        • Clinical Pharmacology of Miami
    • Minnesota
      • St. Paul, Minnesota, Forenede Stater, 55114
        • Prism Research

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 55 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • If female, the subject is at least 2 years post menopausal or is surgically sterile per documentation provided by a third party medical professional and the subject is not pregnant as documented by a negative serum pregnancy test
  • If male, the subject agrees to sexual abstinence and/or to use a highly effective method of birth control during the study period
  • Subject is medically healthy, with no clinically significant abnormalities on medical history or abnormalities observed upon physical examination or 12 lead electrocardiogram (ECG)
  • Subject's fasting clinical laboratory values are within normal limits
  • Subject is a non-smoker and has not used tobacco for a minimum of 3 months
  • Subjects must weigh at least 45 kg and have a Body Mass Index (BMI) of 18-32 kg/m2

Exclusion Criteria:

  • Subject has a positive test for hepatitis C antibody, or positive for hepatitis B surface antigen (HBsAg)
  • Subject has a history of the human immunodeficiency virus (HIV) antibody
  • Subject has a history of severe allergic or anaphylactic reactions
  • Subject has a history of chronic diarrhea
  • Subject has been vaccinated within the last 60 days prior to study drug administration
  • Subject has a previous history of any clinically significant neurological, gastrointestinal, renal, hepatic, pulmonary, metabolic, cardiovascular, psychiatric, endocrine, hematological disorder or disease, or any other medical condition that, in the Investigator's opinion, would preclude participation in the study
  • Subject has had clinically significant illness within 1 month prior to study drug administration
  • Subject has a history of hemorrhoids
  • Subject has a history of drug or alcohol abuse or a positive urine screen for alcohol or drugs of abuse and/or illegal drugs
  • Subject has had treatment with prescription medication (except hormone replacement therapy and acetaminophen), complementary and alternative medicines (CAM) within 14 days, over-the-counter products within 1 week, or alcohol, caffeine or grapefruit juice within 24 hours prior to study drug administration
  • Subject has had treatment with another investigational drug or approved therapy for investigational use within 30 days or 10 half-lives, whichever is longer, prior to study drug administration or has participated in a prior group in the current study
  • Subject has a history of blood donation within 30 days prior to study drug administration or has donated plasma within 7 days prior to study drug administration

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tildeling: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Group A
Lowest dose, all males, fasting
mundtlig
Eksperimentel: Group B
Second lowest dose, all males, fasting
mundtlig
Eksperimentel: Group C
Third lowest dose, all males, fasting
mundtlig
Eksperimentel: Group D
Middle dose, all males, fasting
mundtlig
Eksperimentel: Group E
Third lowest dose, all females, fasting
mundtlig
Eksperimentel: Group F
Third highest dose, all males, fasting then fed
mundtlig
Eksperimentel: Group G
Second highest dose, all males, fasting
mundtlig
Eksperimentel: Group H
Highest dose, all males, fasting
mundtlig
Eksperimentel: Group I
Second highest dose, all females, fasting
mundtlig
Placebo komparator: Placebo Group A
all male, fasting
mundtlig
Placebo komparator: Placebo Group B
all male, fasting then fed
mundtlig
Placebo komparator: Placebo Group C
all female, fasting
mundtlig

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Safety and tolerability assessed through vital signs, electrocardiograms (ECGs), physical exams, reports of adverse events, and analysis of blood and urine samples
Tidsramme: 8 days
8 days
Pharmacokinetic assessment through the analysis of blood and urine samples
Tidsramme: Up to Day 4
Up to Day 4
Pharmacodynamic assessment through the analysis of blood samples
Tidsramme: Up to Day 4
Up to Day 4

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

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. juli 2008

Primær færdiggørelse (Faktiske)

1. november 2008

Studieafslutning (Faktiske)

1. november 2008

Datoer for studieregistrering

Først indsendt

30. juni 2011

Først indsendt, der opfyldte QC-kriterier

30. juni 2011

Først opslået (Skøn)

4. juli 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. juli 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. juni 2011

Sidst verificeret

1. juni 2011

Mere information

Begreber relateret til denne undersøgelse

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 .

Kliniske forsøg med Placebo

3
Abonner