Adults 21 to 65, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3337641Primary· Period 1,2,3,4 (Day 1): Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48 and 72 hours postdose
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3337641
Group
Value
95% CI
Reference Formulation (R-fasted)
66.7
± 40
LY3337641 (T1-fasted)
64.9
± 41
LY3337641 (T1-fed)
56.8
± 44
LY3337641 (T2-fasted)
65.5
± 35
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3337641Primary· Period 1,2,3,4 (Day 1): Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48 and 72 hours postdose
Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from Time Zero to Infinity (AUC\[0-∞\]) of LY3337641
Group
Value
95% CI
Reference Formulation (R-fasted)
373
± 44
LY3337641 (T1-fasted)
371
± 47
LY3337641 (T1-fed)
351
± 42
LY3337641 (T2-fasted)
361
± 43
Adverse events — posted to ClinicalTrials.gov
Time frame: 2 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purposes of this study are to determine:
* If there are any differences in the amount of LY3337641 in the blood/body when it is taken in different formulations. A total of 3 different formulations of LY3337641 are being tested.
* How a high-fat meal affects the amount of LY3337641 in the blood/body.
* How safe and well tolerated LY3337641 is.
The study has four periods. Individuals will participate in all four periods. Each period will include 4 overnight stays (5 days) in the Clinical Research Unit (CRU).
This study is expected to last up to 8 weeks. This includes the initial screening period, the study or dosing period, and the follow up period.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eli Lilly and Company
Last refreshed: 17 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03099148.