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

30 juni 2011 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

72

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Florida
      • Miami, Florida, Förenta staterna, 33014
        • Clinical Pharmacology of Miami
    • Minnesota
      • St. Paul, Minnesota, Förenta staterna, 55114
        • Prism Research

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 55 år (Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Tilldelning: Randomiserad
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Group A
Lowest dose, all males, fasting
oral
Experimentell: Group B
Second lowest dose, all males, fasting
oral
Experimentell: Group C
Third lowest dose, all males, fasting
oral
Experimentell: Group D
Middle dose, all males, fasting
oral
Experimentell: Group E
Third lowest dose, all females, fasting
oral
Experimentell: Group F
Third highest dose, all males, fasting then fed
oral
Experimentell: Group G
Second highest dose, all males, fasting
oral
Experimentell: Group H
Highest dose, all males, fasting
oral
Experimentell: Group I
Second highest dose, all females, fasting
oral
Placebo-jämförare: Placebo Group A
all male, fasting
oral
Placebo-jämförare: Placebo Group B
all male, fasting then fed
oral
Placebo-jämförare: Placebo Group C
all female, fasting
oral

Vad mäter studien?

Primära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juli 2008

Primärt slutförande (Faktisk)

1 november 2008

Avslutad studie (Faktisk)

1 november 2008

Studieregistreringsdatum

Först inskickad

30 juni 2011

Först inskickad som uppfyllde QC-kriterierna

30 juni 2011

Första postat (Uppskatta)

4 juli 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

4 juli 2011

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 juni 2011

Senast verifierad

1 juni 2011

Mer information

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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Kliniska prövningar på Placebo

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