- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01896323
CC-223 and Ketoconazole Drug-Drug Interaction Study
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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Must understand and voluntarily sign a written informed consent form before participation.
- 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.
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.
- Must have a body mass index between 18 and 33 kilograms/meter squared.
- Clinical laboratory tests must be within normal limits or acceptable to the study doctor.
- 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.
- Must have a normal or clinically acceptable 12-lead electrocardiogram.
Exclusion Criteria:
- 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.
- 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.
- 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.
- 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.
- Has any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism and excretion of the study drug, for example, bariatric procedure.
- Donated blood or plasma within 2 months before the first dose of study drug.
- History of drug abuse within 2 years before dosing, or a positive drug screening test reflecting consumption of illicit drugs.
- History of alcohol abuse within 2 years before dosing, or positive alcohol screen.
- 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.
- Exposed to an investigational drug within one month 30 days before the first dose of study drug.
- Smoke more than 10 cigarettes per day, or the equivalent in other tobacco products.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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 navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
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
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Enzymhemmere
- Hormoner, hormonsubstitutter og hormonantagonister
- Cytokrom P-450 CYP3A-hemmere
- Cytokrom P-450 enzymhemmere
- Hormonantagonister
- Antifungale midler
- Steroidesyntesehemmere
- 14-alfa-demetylasehemmere
- Ketokonazol
Andre studie-ID-numre
- CC-223-CP-003
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