En studie av LY3867070 hos friska deltagare
En enkel- och multipelhärdad dosstudie för att utvärdera säkerheten och farmakokinetiken för LY3867070 hos friska deltagare
The purpose of this study is to evaluate how well LY3867070 is tolerated and what side effects may occur in healthy participants. The study drug will be administered orally. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 1
Kontakter och platser
Studieorter
-
-
California
-
Anaheim, California, Förenta staterna, 92801
- Anaheim Clinical Trials, LLC
-
-
Texas
-
Dallas, Texas, Förenta staterna, 75247
- Fortrea Clinical Research Unit
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Are overtly healthy as determined by medical evaluation
- Part C of the study includes only Japanese and Chinese participants
- Have a body weight greater than or equal to 45 kilogram (kg) and also body mass index 18 to 32 kilogram per square meter (kg/m²) inclusive
Exclusion Criteria:
- Have a history or presence of multiple or severe allergies, anaphylactic reaction to prescription or nonprescription drugs, or history of significant atopy
- Have a significant history or current thyroid disease
- Have a significant history of or current psychiatric disorders, rheumatologic, cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (such as Cushing syndrome and hyperaldosteronism), hematological, or neurological disorders
- Are smokers (including electronic cigarettes) within 6 months prior to screening and unwilling to refrain from smoking for the duration of the study.
- Unwilling to undergo skin biopsies (for Part B only)
- Are unwilling to have body hair cut or shaved in cases where hair, in the investigator's opinion, could interfere with noninvasive skin patch
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: LY3867070 (Part A)
Single-Ascending Dose of LY3867070 administered orally |
Administered orally |
|
Experimentell: LY3867070 (Part B)
Multiple-Ascending Doses of LY3867070 administered orally |
Administered orally |
|
Experimentell: LY3867070 (Part C)
Multiple Doses of LY3867070 administered orally |
Administered orally |
|
Placebo-jämförare: Placebo (Parts A-C)
Placebo administered orally |
Administered orally |
|
Experimentell: LY3867070 (Part D)
Drug-Drug Interaction (DDI) administered orally |
Administered orally |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) Considered by the Investigator to be Related to Study Drug Administration
Tidsram: Baseline up to Approximately Week 7
|
A summary of TEAEs regardless of causality, will be reported in the Reported Adverse Events module |
Baseline up to Approximately Week 7
|
|
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Tidsram: Baseline up to Approximately Week 7
|
A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module |
Baseline up to Approximately Week 7
|
|
Number of Participants with One or More Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration
Tidsram: Baseline up to Approximately Week 7
|
A summary of AEs regardless of causality, will be reported in the Reported Adverse Events module |
Baseline up to Approximately Week 7
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3867070
Tidsram: Baseline up to Approximately Week 7
|
PK: AUC of LY3867070 |
Baseline up to Approximately Week 7
|
|
PK: Maximum Concentration (Cmax) of LY3867070
Tidsram: Baseline up to Approximately Week 7
|
PK: Cmax of LY3867070 |
Baseline up to Approximately Week 7
|
|
Part B Pharmacodynamic (PD): Change from Baseline in Gene Expression
Tidsram: Baseline up to Approximately Week 6
|
PD: Change from Baseline in Gene Expression |
Baseline up to Approximately Week 6
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 18873
- J5H-MC-KVAA (Annan identifierare: Eli Lilly and Company)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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