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CC-223 and Ketoconazole Drug-Drug Interaction Study

7. november 2019 opdateret af: Celgene

An Open-Label, Two-Period, Fixed-Sequence Study to Evaluate the Effect of Multiple Doses of Ketoconazole on the Single Dose Pharmacokinetics of CC-223 in Healthy Adult Male Subjects

This is a single-center open-label study to compare how CC-223 (the study drug being investigated) interacts with the drug ketoconazole.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

This is a 2 period study, which lasts about 6 weeks long. About 14 males will be entered into the study, during which they will receive the study drug (a single dose of 20 mg CC-223) 400 mg ketoconazole.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

14

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 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Han

Beskrivelse

Inclusion Criteria:

  1. Must understand and voluntarily sign a written informed consent form before participation.
  2. Must be able to communicate with the study doctor, understand and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules.
  3. Healthy male subject of any race between 18 to 65 years of age, and in good health as determined by a physical examination.

    - For males: Agree to use barrier contraception not made of natural (animal) membrane (for example, latex or polyurethane condoms are acceptable) when engaging in sexual activity with a female of child-bearing potential while on study medication, and for at least 28 days after the last dose of study medication.

  4. Must have a body mass index between 18 and 33 kilograms/meter squared.
  5. Clinical laboratory tests must be within normal limits or acceptable to the study doctor.
  6. Must not have a fever, with a blood pressure between 90/50 to 140/90 millimeters of mercury, and pulse rate: between 40 to 110 beats per minute.
  7. Must have a normal or clinically acceptable 12-lead electrocardiogram.

Exclusion Criteria:

  1. History of any clinically significant and relevant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major disorders.
  2. Any condition which places the subject at unacceptable risk if he were to participate in the study, or confounds the ability to interpret data from the study.
  3. Used any prescribed or topical medication within one month before the first dose of study drug, unless consultation between the sponsor and the study doctor.
  4. Used any non-prescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 2 weeks (30 days for St. John's Wort®) of the first dose administration, unless sponsor agreement is obtained.
  5. Has any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism and excretion of the study drug, for example, bariatric procedure.
  6. Donated blood or plasma within 2 months before the first dose of study drug.
  7. History of drug abuse within 2 years before dosing, or a positive drug screening test reflecting consumption of illicit drugs.
  8. History of alcohol abuse within 2 years before dosing, or positive alcohol screen.
  9. Known to have serum hepatitis or known to be a carrier of the hepatitis B surface antigen, or hepatitis C antibody, or have a positive result to the test for Human Immune virus antibodies at Screening.
  10. Exposed to an investigational drug within one month 30 days before the first dose of study drug.
  11. Smoke more than 10 cigarettes per day, or the equivalent in other tobacco products.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: CC-223
CC-223 administration on study day 1 of Period 1 and study day 5 of Period 2
CC-223 20 mg tablets
Aktiv komparator: Ketokonazole
Ketoconazole administration on study days 1 through 8 of Period 2
Ketoconazole 400 mg tablets
Andre navne:
  • Nizoral

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pharmacokinetics
Tidsramme: up to 96 hours post dose
AUC-area under the plasma concentration-time curve;
up to 96 hours post dose
Pharmacokinetics
Tidsramme: up to 96 hours post dose
Cmax-maximum observed plasma concentration
up to 96 hours post dose
Pharmacokinetics
Tidsramme: up to 96 hours post dose
Tmax - Time to maximum observed plasma concentration
up to 96 hours post dose
Pharmacokinetics
Tidsramme: up to 96 hours post dose
t½ - terminal elimination half-life in plasma
up to 96 hours post dose

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adverse Events
Tidsramme: Up to 28 days after last dose of study drug
Number of subjects with adverse events
Up to 28 days after last dose of study drug

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 (Faktiske)

1. juli 2013

Primær færdiggørelse (Faktiske)

1. august 2013

Studieafslutning (Faktiske)

1. august 2013

Datoer for studieregistrering

Først indsendt

8. juli 2013

Først indsendt, der opfyldte QC-kriterier

10. juli 2013

Først opslået (Skøn)

11. juli 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. november 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. november 2019

Sidst verificeret

1. november 2019

Mere information

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 CC-223

Abonner