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| ID | Type | Description | Link |
|---|---|---|---|
| Morf-440-101 | Other Identifier | Eli Lilly and Company | |
| J6O-MC-UMAA | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to evaluate the safety and tolerability of single ascending doses of MORF-440 administered to healthy participants single-ascending dose (SAD) and maximum ascending dose (MAD) substudy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A1 | Experimental | Participants received LY4292009 orally. |
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| Cohort A2 | Experimental | Participants received LY4292009 orally. |
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| Cohort A3 | Experimental | Participants received LY4292009 orally. |
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| Cohort A4 | Experimental | Participants received LY4292009 orally. |
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| Cohort A5 | Experimental | Participants received LY4292009 orally. |
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| Cohort A6 (Optional) | Experimental | Participants received LY4292009 orally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY4292009 | Drug | Administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs) in SAD (Cohort A1-A6) and MAD (Cohort B1-B4) | Baseline to Study Completion (Up to Day 17) | |
| Percentage of Participants with TEAEs and SAEs in SAD (Cohort A1-A6) and MAD (Cohort B1-B4) | Baseline to Study Completion (Up to Day 7) | |
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) in (Cohort A1-A6) and MAD (Cohort B1-B4) | Baseline to Study Completion (Up to Day 7) | |
| Change from Baseline in Laboratory Parameter and Vital Signs in SAD (Cohort A1-A6) and MAD (Cohort B1-B4) | Baseline to Study Completion (Up to Day 7) | |
| Number of Participants with Clinically Significant Changes in Cardiovascular Evaluation in SAD (Cohort A1-A6) and MAD (Cohort B1-B4) | Baseline to Study Completion (Up to Day 7) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) in SAD (Cohort A1-A6) and MAD (Cohort B1-B4) | Maximum observed plasma concentration | SAD Cohorts: Predose up to Day 4 Postdose |
| PK: Time to Maximum Concentration (Tmax) in SAD (Cohort A1-A6) and MAD (Cohort B1-B4) |
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Inclusion Criteria:
Body mass index (BMI) within 18.0 kg/m² to 30.0 kg/m², inclusive
If male, meets one of the following:
if female, meets one of the following:
is of childbearing potential and agrees to use an acceptable contraceptive method.
is of non-childbearing potential, defined as either:
is in a postmenopausal state:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altasciences Company Inc. | Mount Royal | H3p 3p1 | Canada |
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| Cohort B1 |
| Experimental |
Participants received LY4292009 orally. |
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| Cohort B2 | Experimental | Participants received LY4292009 orally. |
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| Cohort B3 | Experimental | Participants received LY4292009 orally. |
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| Cohort B4 (Optional) | Experimental | Participants received LY4292009 orally. |
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| Placebo | Placebo Comparator | Participants receive placebo. |
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| Placebo | Drug | Administered orally. |
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Time to reach Cmax, defined as the first point if multiple maximum values occur. |
| SAD Cohorts: Predose up to Day 4 Postdose |
| PK: Area Under the Concentration Curve (AUC) in SAD (Cohort A1-A6) and MAD (Cohort B1-B4) | SAD Cohorts: Predose up to Day 4 Postdose |
| PK: Time to Half Life (T1/2) in SAD (Cohort A1-A6) and MAD (Cohort B1-B4) | Apparent first-order terminal phase half-life, calculated as 0.693/λ | SAD Cohorts: Predose up to Day 4 Postdose |
| PK: AUC From Time Zero to Infinity (AUC 0-inf) in SAD (Cohort A1-A6) and MAD (Cohort B1-B4) | Area under the concentration-time curve from time 0 extrapolated to infinity. Calculated as the sum of AUC0-t plus the ratio of the last measurable concentration to the terminal phase rate constant (λz). | SAD Cohorts: Predose up to Day 4 Postdose |
| PK: CL/F in SAD (Cohort A1-A6) and MAD (Cohort B1-B4) | Apparent total clearance after oral administration, calculated as Dose/AUC0-inf | SAD Cohorts: Predose up to Day 4 Postdose |
| PK: Vd/F in SAD (Cohort A1-A6) and MAD (Cohort B1-B4) | Apparent volume of distribution during terminal phase after oral administration, calculated as Dose/[λz*AUC0-inf] | SAD Cohorts: Predose up to Day 4 Postdose |
| PK: Urine: Ae(total) in SAD (Cohort A1-A6) and MAD (Cohort B1-B4) | otal amount of urinary excretion (cohorts participating in urinary PK sample collection only) | SAD Cohorts: Predose up to Day 4 Postdose |
| PK: CLR in SAD (Cohort A1-A6) and MAD (Cohort B1-B4) | Clearance of urinary excretion (cohorts participating in urinary PK sample collection only), calculated as Ae/AUC0-inf | SAD Cohorts: Predose up to Day 4 Postdose |