Clinical trial NCT04823702: Study of Aldafermin (NGM282) in Participants With Impaired Hepatic Function
Official title: A Phase I, Open-label, Parallel-group Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Dose of Aldafermin in Subjects With Impaired Hepatic Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Impaired Hepatic Function
Lead sponsor: NGM Biopharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2021-04-01
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Pharmacokinetics (PK) of a single dose aldafermin
timeFrame: 4 days
measure: Pharmacokinetics of a single dose of aldafermin
timeFrame: 4 days
Secondary outcomes:
measure: Type and frequency of adverse events (Day 1 through Day 11)
timeFrame: 11 days
Other outcomes:
measure: Pharmacodynamics (PD) of biomarker 7-alpha-hydroxy-4-cholesten-3-one (C4)
timeFrame: 6 and 24 hours post dose
measure: Pharmacodynamics (PD) of biomarker 7-alpha-hydroxy-4-cholesten-3-one (C4)
timeFrame: 6 and 24 hours post dose
Locations:
city: Miami
country: United States
facility: NGM Clinical Study Site 110
state: Florida
city: Orlando
country: United States
facility: NGM Clinical Study Site 111
state: Florida
city: San Antonio
country: United States
facility: NGM Clinical Study Site 113
state: Texas
Study officials:
affiliation: NGM Biopharmaceuticals, Inc
name: NGM Study Director
role: STUDY_DIRECTOR
References: