Impaired Hepatic Function
Conditions
Brief summary
This is an evaluation of Aldafermin (NGM282) in an open-label, single-dose and parallel group study in participants with Impaired Hepatic Function
Interventions
BIOLOGICALAldafermin
Biological: Aldafermin (NGM282) Subcutaneous Injection
Sponsors
NGM Biopharmaceuticals, Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Males or females, 18 - 75 years of age, inclusive 2. Able to comprehend and willing to sign an informed consent form (ICF) 3. Willing and able to comply with all study requirements 4. BMI 18 - 40 kg/m2, inclusive at Screening 5. Stable medication regimen - no medication initiation or dose change within 7 days or 5 half-lives (whichever is longer) prior to dosing of the study medication. 6. Non-pregnant, non-lactating females. Female subjects of childbearing potential and male subjects with a female sexual partner of childbearing potential must agree to consistent and adequate birth control. One of the following forms of contraception is required: 1. Condom 2. Hormone containing contraceptive 3. Intrauterine device with a failure rate \< 1% per year 4. Cervical cap or diaphragm with spermicidal agent 5. Tubal sterilization 6. Vasectomy in male partner 7. Sexual abstinence 7. Negative test for drugs of abuse at Screening unless they are currently prescribed 8. Negative human immunodeficiency virus (HIV) antibody screen at Screening
Exclusion criteria
1. Any acute disease or condition being treated by medical therapy (prescription or over the counter) known to possibly impact hepatic function 2. History of or recent (\< 6 weeks) treatment for a chronic condition with a medication that is known to have hepatotoxic potential. 3. Any significant physical injury or surgical procedure within 6 weeks of Screening 4. Uncontrolled diabetes (hemoglobin A1c \[HbA1c\] \> 9.5%) 5. Uncontrolled hypertension (systolic blood pressure \[SBP\] \> 180 mmHg on ≥ 3 medications of different classes for blood pressure control) 6. Have received any investigational medication within 30 days or 5 half-lives, whichever is longer, prior to study dosing 7. Subjects should not have donated blood within 60 days of study entry or plasma within 7 days of study entry. Subjects must also refrain from blood donation from clinic admission, throughout the study period, and continuing for at least 30 days following the last dose of study medication. 8. Positive urine drug screen at Screening that is not otherwise explained by a permitted concomitant medication 9. History of alcoholism in the 6 months prior to Screening 10. Inadequate peripheral venous access
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK) of a single dose aldafermin | 4 days | Maximum observed plasma concentration (Cmax) of aldafermin (Day 1 through Day 4) |
| Pharmacokinetics of a single dose of aldafermin | 4 days | Area under the concentration-time curve from time zero extrapolated to infinity (AUC infinity) of aldafermin (Day 1 through Day 4) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Type and frequency of adverse events (Day 1 through Day 11) | 11 days | Frequency, severity, timing, and/or duration of treatment-emergent adverse events (TEAE) and serious adverse events (SAEs) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pharmacodynamics (PD) of biomarker 7-alpha-hydroxy-4-cholesten-3-one (C4) | 6 and 24 hours post dose | Absolute change from baseline |
Countries
United States
Outcome results
None listed