ALT-801 DDI Study in Healthy Volunteers

NASH - Nonalcoholic Steatohepatitis Clinical Trial

Official title:

An Open-label Study of the Effect of ALT-801 on the Pharmacokinetics of Metformin, Warfarin, Atorvastatin, Digoxin, and the Combined Oral Contraceptive Ethinylestradiol/Levonorgestrel in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04972396
• Other study ID #: ALT-801-103
• Status: Completed
• Phase: Phase 1
• Start date: October 5, 2021
• Est. completion date: May 15, 2022

Study information

• Verified date: December 2022
• Source: Altimmune, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 1, open-label, drug-drug interaction (DDI) study of ALT-801 under steady state conditions on concomitantly administered medications in healthy subjects. The study will evaluate the effect of ALT-801 on the pharmacokinetics (PK) of metformin, warfarin, atorvastatin, digoxin, and the combined oral contraceptive (OC) ethinylestradiol/levonorgestrel. The study will be conducted in 3 parts, as described below. Each part will have 2 periods in a fixed sequence, where the first period is without ALT-801 administration and the second is with ALT-801 at steady state.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 15, 2022
• Est. primary completion date: May 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Male or female healthy volunteers, age 18 to 55 years, inclusive
• Body mass index (BMI) 25.0- 40.0 kg/m2
• Able and willing to provide written informed consent prior to entry into the study

Exclusion Criteria:

• Women who are pregnant or breastfeeding
• History of diabetes or use of medications for the treatment of diabetes, or hyperglycemia or HbA1c = 6.5%
• History of pancreatitis or hypersensitivity reaction to GLP-1 analogues

Related Conditions & MeSH terms

• Fatty Liver
• NASH - Nonalcoholic Steatohepatitis
• Non-alcoholic Fatty Liver Disease

Intervention

Drug:
• ALT-801
Injected subcutaneously (SC)
• Metformin
Taken by mouth (PO)
• Atorvastatin
Taken by mouth (PO)
• Warfarin
Taken by mouth (PO)
• Digoxin
Taken by mouth (PO)
• Ethinylestradiol and Levonorgestrel
Taken by mouth (PO)

Locations

Country	Name	City	State
Australia	CMAX Clinical Research	Adelaide	South Australia
Australia	Q-Pharm	Herston	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Altimmune, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Plasma Concentration Versus Time Curve (AUC) of metformin and atorvastatin/warfarin and digoxin in presence of steady state ALT-801		Baseline and Day 36
Primary	Area Under the Plasma Concentration Versus Time Curve (AUC) of ethinylestradiol and levonorgestrel in presence of steady state ALT-801		Baseline and Day 43
Secondary	Cmax and Tmax of metformin and atorvastatin/warfarin and digoxin		Day 36
Secondary	Cmax and Tmax of ethinylestradiol and levonorgestrel		Day 43
Secondary	The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)		Up to Day 77