A Study of LY3185643 and rGlucagon in Healthy Participants
27. september 2019 oppdatert av: Eli Lilly and Company
A Randomized, 9-Way, Single-Dose, Crossover Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of LY3185643 and rGlucagon in Healthy Subjects
The purpose of this study is to determine how the body handles LY3185643 and rGlucagon and what effects LY3185643 and rGlucagon have on the body. This study will also help to determine if LY3185643 is safe and well-tolerated.
This study will last at least 35 days, not including screening.
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
23
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, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal 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 60 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Are overtly healthy as determined by medical history and physical examination
- Body mass index of 18.0 to 30.0 kilograms per square meter (kg/m²)
Exclusion Criteria:
- Have participated, within the last 30 days, in a clinical trial involving an investigational product
- Known allergies to LY3185643 or rGlucagon, related compounds, or any components of the formulation
- History or electrocardiogram (ECG) evidence of heart block, or any abnormality in the 12-lead ECG
- Abnormal blood pressure
- History of recurring symptomatic postural hypotension irrespective of the decrease in blood pressure, or asymptomatic postural hypotension at screening as defined as a decrease in systolic blood pressure greater than or equal to (≥) 20 millimeter of Mercury (mm Hg) within 3 minutes when changing from supine to standing position
- History of vasovagal response such as fainting
- History of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
- History of/current insulinoma and/or pheochromocytoma
- Have used systemic glucocorticoids within 3 months before entry into the study
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: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: LY3185643
LY3185643 administered subcutaneous (SC)
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Administered SC
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Eksperimentell: rGlucagon
rGlucagon administered subcutaneous (SC)
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Administered SC
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3185643 and rGlucagon
Tidsramme: 0 (pre-dose), 15, 30, 60, 120 and 180 minutes post-dose
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Maximum observed plasma concentration (Cmax) was assessed for LY3185643 and rGlucagon.
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0 (pre-dose), 15, 30, 60, 120 and 180 minutes post-dose
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Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3185643 and rGlucagon
Tidsramme: 0 (pre-dose), 15, 30, 60, 120 and 180 minutes post-dose
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Area under the concentration versus time curve from zero to infinity (AUC0-inf) was assessed for LY3185643 and rGlucagon.
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0 (pre-dose), 15, 30, 60, 120 and 180 minutes post-dose
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Pharmacodynamics (PD): Change From Baseline in Maximum Concentration (Cmax) of Blood Glucose of LY3185643 and rGlucagon
Tidsramme: -5, 0 (pre-dose), 5, 10, 15, 22, 30, 45, 60, 75, 90, 105, 120, 150, 180 minutes post-dose
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Cmax was assessed for LY3185643 and rGlucagon.
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-5, 0 (pre-dose), 5, 10, 15, 22, 30, 45, 60, 75, 90, 105, 120, 150, 180 minutes post-dose
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Pharmacodynamics (PD): Change From Baseline in Maximum Concentration (Cmax) of C-peptide of LY3185643 and rGlucagon
Tidsramme: -5, 0 (predose), 5, 15, 30, 60 and 120 minutes post-dose
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Cmax was assessed for C-peptide of LY3185643 and rGlucagon
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-5, 0 (predose), 5, 15, 30, 60 and 120 minutes post-dose
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Pharmacodynamics (PD): Change From Baseline in Area Under the Concentration Time Curve (AUC) of Blood Glucose of LY3185643 and rGlucagon
Tidsramme: -5, 0 (pre-dose), 5, 10, 15, 22, 30, 45, 60, 75, 90, 105, 120, 150, 180 minutes post-dose
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Area under the concentration versus time curve from time zero to 3 hours [AUC (0-3)] was assessed for LY3185643 and rGlucagon.
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-5, 0 (pre-dose), 5, 10, 15, 22, 30, 45, 60, 75, 90, 105, 120, 150, 180 minutes post-dose
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Pharmacodynamics (PD): Change From Baseline in Area Under the Concentration Time Curve (AUC) of C-Peptide of LY3185643 and rGlucagon
Tidsramme: -5, 0 (pre-dose), 5, 15, 30, 60 and 120 minutes post-dose
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Area under the concentration versus time curve from time zero to 3 hours [AUC (0-3)] was assessed for C-peptide of LY3185643 and rGlucagon.
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-5, 0 (pre-dose), 5, 15, 30, 60 and 120 minutes post-dose
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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 (Faktiske)
1. november 2016
Primær fullføring (Faktiske)
24. januar 2017
Studiet fullført (Faktiske)
1. mars 2017
Datoer for studieregistrering
Først innsendt
31. oktober 2016
Først innsendt som oppfylte QC-kriteriene
31. oktober 2016
Først lagt ut (Anslag)
1. november 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
30. september 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. september 2019
Sist bekreftet
1. september 2019
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 16502
- I8Z-MC-APCA (Annen identifikator: Eli Lilly and Company)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.
This access is provided in a timely fashion after the primary publication is accepted.
Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com.
Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.
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