Healthy
Conditions
Brief summary
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.
Interventions
DRUGLY4292009
Administered orally
DRUGPlacebo
Administered orally.
Sponsors
Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index (BMI) within 18.0 kg/m² to 30.0 kg/m², inclusive * If male, meets one of the following: * can procreate and agree to use one of the accepted to use one of the accepted contraceptive regimens and not to donate sperm from the first study drug administration to at least 90 days after the last drug administration. * is unable to procreate; defined as surgically sterile (i.e., has undergone a vasectomy at least 180 days prior to the first study drug administration) * 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: * Surgically sterile (i.e., has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or * is in a postmenopausal state: * At least 1 year without menses and without an alternative medical condition prior to the screening, and follicle stimulating hormone (FSH) levels ≥ 40 mIU/mL at screening or at least 1 year without menses and without an alternative medical condition prior to the screening, follicle stimulating hormone FSH levels \< 40 milli-international units per milliliter (mIU/mL) and estradiol serum level ≤150 picomole/Liter (pmol/L) at screening
Exclusion criteria
* Female who is lactating or who is pregnant according to the pregnancy test at screening or prior to the first study drug administration, or planning to become pregnant during the study period up to 30 days after the last study drug administration * Nicotine intake (e.g., smoking, nicotine patch, nicotine chewing gum, chewing tobacco, electronic cigarettes) within 1 month before screening and/or inability to refrain from nicotine from screening until the end of the study
Design outcomes
Primary
| Measure | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) in SAD (Cohort A1-A6) and MAD (Cohort B1-B4) | SAD Cohorts: Predose up to Day 4 Postdose | Maximum observed plasma concentration |
| PK: Time to Maximum Concentration (Tmax) in SAD (Cohort A1-A6) and MAD (Cohort B1-B4) | SAD Cohorts: Predose up to Day 4 Postdose | Time to reach Cmax, defined as the first point if multiple maximum values occur. |
| 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) | SAD Cohorts: Predose up to Day 4 Postdose | Apparent first-order terminal phase half-life, calculated as 0.693/λ |
| PK: AUC From Time Zero to Infinity (AUC 0-inf) in SAD (Cohort A1-A6) and MAD (Cohort B1-B4) | SAD Cohorts: Predose up to Day 4 Postdose | 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). |
| PK: CL/F in SAD (Cohort A1-A6) and MAD (Cohort B1-B4) | SAD Cohorts: Predose up to Day 4 Postdose | Apparent total clearance after oral administration, calculated as Dose/AUC0-inf |
| PK: Vd/F in SAD (Cohort A1-A6) and MAD (Cohort B1-B4) | SAD Cohorts: Predose up to Day 4 Postdose | Apparent volume of distribution during terminal phase after oral administration, calculated as Dose/\[λz\*AUC0-inf\] |
| PK: Urine: Ae(total) in SAD (Cohort A1-A6) and MAD (Cohort B1-B4) | SAD Cohorts: Predose up to Day 4 Postdose | otal amount of urinary excretion (cohorts participating in urinary PK sample collection only) |
| PK: CLR in SAD (Cohort A1-A6) and MAD (Cohort B1-B4) | SAD Cohorts: Predose up to Day 4 Postdose | Clearance of urinary excretion (cohorts participating in urinary PK sample collection only), calculated as Ae/AUC0-inf |
Countries
Canada
Contacts
STUDY_DIRECTORCall 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
Outcome results
None listed