Study of Aldafermin (NGM282) in Participants With Impaired Hepatic Function
- Conditions
- Impaired Hepatic Function
- Interventions
- Biological: Aldafermin
- Registration Number
- NCT04823702
- Lead Sponsor
- NGM Biopharmaceuticals, Inc
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
-
Males or females, 18 - 75 years of age, inclusive
-
Able to comprehend and willing to sign an informed consent form (ICF)
-
Willing and able to comply with all study requirements
-
BMI 18 - 40 kg/m2, inclusive at Screening
-
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.
-
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:
- Condom
- Hormone containing contraceptive
- Intrauterine device with a failure rate < 1% per year
- Cervical cap or diaphragm with spermicidal agent
- Tubal sterilization
- Vasectomy in male partner
- Sexual abstinence
-
Negative test for drugs of abuse at Screening unless they are currently prescribed
-
Negative human immunodeficiency virus (HIV) antibody screen at Screening
- Any acute disease or condition being treated by medical therapy (prescription or over the counter) known to possibly impact hepatic function
- History of or recent (< 6 weeks) treatment for a chronic condition with a medication that is known to have hepatotoxic potential.
- Any significant physical injury or surgical procedure within 6 weeks of Screening
- Uncontrolled diabetes (hemoglobin A1c [HbA1c] > 9.5%)
- Uncontrolled hypertension (systolic blood pressure [SBP] > 180 mmHg on ≥ 3 medications of different classes for blood pressure control)
- Have received any investigational medication within 30 days or 5 half-lives, whichever is longer, prior to study dosing
- 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.
- Positive urine drug screen at Screening that is not otherwise explained by a permitted concomitant medication
- History of alcoholism in the 6 months prior to Screening
- Inadequate peripheral venous access
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Child-Pugh A (Mild Hepatic Impairment) & Healthy Matched Aldafermin Administered by subcutaneous injection Child-Pugh B (Moderate Hepatic Impairment) & Healthy Matched Aldafermin Administered by subcutaneous injection Child-Pugh C (Severe Hepatic Impairment) & Healthy Matched Aldafermin Administered by subcutaneous injection
- Primary Outcome Measures
Name Time Method 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)
Pharmacokinetics (PK) of a single dose aldafermin 4 days Maximum observed plasma concentration (Cmax) of aldafermin (Day 1 through Day 4)
- Secondary Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (3)
NGM Clinical Study Site 110
🇺🇸Miami, Florida, United States
NGM Clinical Study Site 113
🇺🇸San Antonio, Texas, United States
NGM Clinical Study Site 111
🇺🇸Orlando, Florida, United States