A Study of [¹⁴C]-LY3202626 in Healthy Male Participants
22. mars 2021 oppdatert av: Eli Lilly and Company
Disposition of [¹⁴C]-LY3202626 Following Oral Administration in Healthy Male Subjects
The purpose of this study is to measure how much of the specially prepared study drug, LY3202626, containing radiolabeled carbon [¹⁴C] gets into the blood stream and how long it takes the body to get rid of it.
Information about any side effects that may occur will also be collected.
Participants will stay at a clinical research unit (CRU). The study will last about 28 days (check in to follow-up) for each participant.
This study is for research purposes only and is not intended to treat any medical condition.
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
6
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Wisconsin
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Madison, Wisconsin, Forente stater, 53704
- Covance Clinical Research Unit Inc.
-
-
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
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Mann
Beskrivelse
Inclusion Criteria:
- Are overtly healthy males, as determined by physical examination, clinical laboratory tests, medical history and electrocardiogram (ECG)
- Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m²) inclusive at screening
Exclusion Criteria:
- Have participated in a [¹⁴C]-study within the last 6 months prior to admission for this study
- Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
- Have consumed grapefruits or grapefruit-containing products, Seville oranges or Seville orange-containing products, star fruits or star fruit-containing products within 7 days prior to dosing or intend to consume during the study
- Have a history of constipation or have had acute constipation within 3 weeks prior to admission
- Are currently or have been smokers or users of tobacco or nicotine replacement products within the 3 months prior to admission and/or have positive cotinine at screening or check-in
- Exposure to significant diagnostic, therapeutic, or employment-related radiation within 12 months prior to dosing (e.g., serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring)
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: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: [¹⁴C]-LY3202626
Single oral dose of LY3202626 containing 100 micro curies of radioactivity
|
Administered as solution by mouth
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Fecal Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Tidsramme: Predose, 6, 12, 24, 48, 72 Hours At 24 Hour Intervals Until Release Criteria Met
|
Fecal excretion of radioactivity over time expressed as a percentage of the total radioactive dose administered.
|
Predose, 6, 12, 24, 48, 72 Hours At 24 Hour Intervals Until Release Criteria Met
|
|
Urinary Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Tidsramme: Predose, 6, 12, 24, 48, 72 Hours At 24 Hour Intervals Until Release Criteria Met
|
Urinary excretion of radioactivity over time was expressed as a percentage of the total radioactive dose administered
|
Predose, 6, 12, 24, 48, 72 Hours At 24 Hour Intervals Until Release Criteria Met
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Plasma Radioactivity Pharmacokinetics Maximum Observed Concentration (Cmax)
Tidsramme: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria Met
|
Plasma radioactivity pharmacokinetics were measured by the maximum observed concentration (Cmax).
|
Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria Met
|
|
Plasma Radioactivity Pharmacokinetics Area Under the Concentration-time Curve From Time Zero to Infinity (AUC[0-∞])
Tidsramme: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria Met
|
Plasma radioactivity pharmacokinetics were measured by the area under the concentration-time curve from time zero to infinity (AUC[0-∞]).
|
Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria Met
|
|
Plasma Radioactivity Pharmacokinetics Area Under the Concentration-time Curve From Time Zero to the Last Timepoint With a Measurable Concentration (AUC[0-tlast])
Tidsramme: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria Met
|
Plasma radioactivity pharmacokinetics were measured by the area under the concentration-time curve from time zero to the last timepoint with a measurable concentration (AUC[0-tlast]).
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Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria Met
|
|
Total Number of Metabolites Representing at Least 10% of the Total Radioactivity in Plasma
Tidsramme: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 Hours Postdose
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Total number of metabolites were identified in at least 10% of the total radioactivity in plasma.
|
Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 Hours Postdose
|
|
Total Number of Metabolites in Excreta (Urine and Feces) That Represent at Least 10% of the Dose of Radioactivity
Tidsramme: From Dosing Until Release Criteria Is Met
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The total number of metabolites identified in excreta (urine and feces) that represent at least 10% of the dose of radioactivity
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From Dosing Until Release Criteria Is Met
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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. september 2015
Primær fullføring (Faktiske)
1. november 2015
Studiet fullført (Faktiske)
1. november 2015
Datoer for studieregistrering
Først innsendt
17. september 2015
Først innsendt som oppfylte QC-kriteriene
17. september 2015
Først lagt ut (Anslag)
21. september 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. april 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. mars 2021
Sist bekreftet
1. mars 2021
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 15566
- I7X-EW-LLCC (Annen identifikator: Eli Lilly and Company)
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