A Study of LY2409021 Formulations and the Effect of Food
19. november 2018 oppdatert av: Eli Lilly and Company
LY2409021 Formulation Bridging and Food Effect Study
The purposes of this study are to compare how much of LY2409021 enters the bloodstream and how long the body takes to get rid of the drug when different formulations of LY2409021 are given, and when LY2409021 is taken with or without food.
The study will be conducted in 2 cohorts. Each cohort will have 3 study periods consisting of 3 formulations of LY2409021. Participants in each cohort will receive the same all 3 formulations using a randomized sequence crossover design. There is a washout period of at least 14 days between dosing periods.
There will be an interim analysis after Cohort 1 completes study Period 2. Cohort 2 will not begin enrolling until this analysis is complete. The need to enroll Cohort 2 will be determined by the outcome of the interim analysis.
Studieoversikt
Status
Fullført
Forhold
Studietype
Intervensjonell
Registrering (Faktiske)
35
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Singapore, Singapore
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your person physician.
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
21 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Must be healthy male or a healthy female who cannot become pregnant
- Must have body mass index (BMI) of 18.5 to 32 kilograms per meter squared (kg/m²), inclusive
- Blood pressure as well as blood and urine laboratory test results must be acceptable for the study
- The veins must be suitable for easy blood collection
- Must be willing to be available for the whole study and be willing to follow study procedures
Exclusion Criteria:
- Were in another new drug or medical research study in the last 30 days
- Have previously taken part in this study or any other study with LY2409021
- Have taken LY2409021, or drugs similar to LY2409021 before and was found to be allergic to the drug
- Currently have or used to have health problems or laboratory test results that in the opinion of the doctor, could interfere with understanding the results of this study
- Electrocardiogram (ECG) readings are not suitable for the study
- Are infected with hepatitis B
- Are infected with human immunodeficiency disease virus (HIV)
- Are using or intend to use over-the-counter medication or prescription medications within 14 days, from the start of the first study dosing until end of study
- Have a regular alcohol intake greater than 21 units per week (males) and 14 units per week (females) or are not willing to abstain from alcohol while in the research unit
- Smoke more than 10 cigarettes per day or are not willing to abstain from smoking while at the clinic
- Have a history of drug or alcohol abuse
- Have donated 450 milliliters (mL) or more of blood in the last 3 months
- Are unwilling or unable to comply with dietary requirements/restrictions during the study
- The study doctor thinks the participant should not participate for any other reasons
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Cohort 1 - LY2409021 reference form
A 20 milligram (mg) LY2409021 dose, reference form administered orally in the fasted state
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Administered orally
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Eksperimentell: Cohort 1 - LY2409021 medium test form fed
Single 20 mg LY2409021 test form with medium particle size administered orally immediately after ingestion of a standardized high-fat meal
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Administered orally
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Eksperimentell: Cohort 1 - LY2409021 medium test form fasted
Single 20 mg LY2409021 test form with medium particle size administered orally in the fasted state
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Administered orally
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Eksperimentell: Cohort 2 - LY2409021 low test form fasted
Single 20 mg LY2409021 test form with low particle size administered orally in the fasted state
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Administered orally
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Eksperimentell: Cohort 2 - LY2409021 medium test form fasted
Single 20 mg LY2409021 test form with medium particle size administered orally in the fasted state
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Administered orally
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Eksperimentell: Cohort 2 - LY2409021 high test form fasted
Single 20 mg LY2409021 test form with high particle size administered orally in the fasted state
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Administered orally
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Medium Test Form to Reference Form
Tidsramme: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
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AUC from time 0 to infinity (AUC0-∞).
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Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
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Pharmacokinetics, Maximum Concentration (Cmax): Medium Test Form to Reference Form
Tidsramme: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
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Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Standardized High Fat Meal to Fasting
Tidsramme: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
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AUC from time 0 to infinity (AUC0-∞).
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Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
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Pharmacokinetics, Maximum Concentration (Cmax): Standardized High Fat Meal to Fasting
Tidsramme: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
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Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
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Pharmacokinetics, Time to Maximum Concentration (Tmax)
Tidsramme: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
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Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
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Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Low and High Particle Size to Medium Particle Size
Tidsramme: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
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AUC from time 0 to infinity (AUC0-∞).
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Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
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Pharmacokinetics, Concentration Maximum (Cmax): Low and High Particle Size to Medium Particle Size
Tidsramme: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
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Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. april 2011
Primær fullføring (Faktiske)
1. oktober 2011
Studiet fullført (Faktiske)
1. oktober 2011
Datoer for studieregistrering
Først innsendt
13. mai 2011
Først innsendt som oppfylte QC-kriteriene
13. mai 2011
Først lagt ut (Anslag)
17. mai 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. mars 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. november 2018
Sist bekreftet
1. november 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 14194
- I1R-FW-GLBQ (Annen identifikator: Eli Lilly and Company)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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