Study of Aldafermin (NGM282) in Participants With Impaired Hepatic Function

Impaired Hepatic Function Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04823702
• Other study ID #: 282-HI-104
• Status: Completed
• Phase: Phase 1
• Start date: April 1, 2021
• Est. completion date: November 19, 2021

Study information

• Verified date: December 2021
• Source: NGM Biopharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an evaluation of Aldafermin (NGM282) in an open-label, single-dose and parallel group study in participants with Impaired Hepatic Function

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 19, 2021
• Est. primary completion date: November 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Impaired Hepatic Function

Intervention

Biological:
• Aldafermin
Biological: Aldafermin (NGM282) Subcutaneous Injection

Locations

Country	Name	City	State
United States	NGM Clinical Study Site 110	Miami	Florida
United States	NGM Clinical Study Site 111	Orlando	Florida
United States	NGM Clinical Study Site 113	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
NGM Biopharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pharmacodynamics (PD) of biomarker 7-alpha-hydroxy-4-cholesten-3-one (C4)	Absolute change from baseline	6 and 24 hours post dose
Other	Pharmacodynamics (PD) of biomarker 7-alpha-hydroxy-4-cholesten-3-one (C4)	Percent change from baseline	6 and 24 hours post dose
Primary	Pharmacokinetics (PK) of a single dose aldafermin	Maximum observed plasma concentration (Cmax) of aldafermin (Day 1 through Day 4)	4 days
Primary	Pharmacokinetics of a single dose of aldafermin	Area under the concentration-time curve from time zero extrapolated to infinity (AUC infinity) of aldafermin (Day 1 through Day 4)	4 days
Secondary	Type and frequency of adverse events (Day 1 through Day 11)	Frequency, severity, timing, and/or duration of treatment-emergent adverse events (TEAE) and serious adverse events (SAEs)	11 days