NCT04972396

Pemvidutide (ALT-801) DDI Study in Healthy Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Altimmune, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, open-label, drug-drug interaction (DDI) study of pemvidutide (ALT-801) under steady state conditions on concomitantly administered medications in healthy subjects. The study will evaluate the effect of pemvidutide on the pharmacokinetics (PK) of metformin, warfarin, atorvastatin, digoxin, and the combined oral contraceptive (COC) 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 pemvidutide administration and the second is with pemvidutide at steady state.

Conditions

• NASH - Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	Pemvidutide	Injected subcutaneously (SC)
DRUG	Metformin	Taken by mouth (PO)
DRUG	Atorvastatin	Taken by mouth (PO)
DRUG	Warfarin	Taken by mouth (PO)
DRUG	Digoxin	Taken by mouth (PO)
DRUG	Ethinylestradiol and Levonorgestrel	Taken by mouth (PO)

Timeline

• Start date: 2021-09-15
• Primary completion: 2022-05-15
• Completion: 2022-05-15
• First posted: 2021-07-22
• Last updated: 2025-06-24

Locations

2 sites across 1 country: Australia

Regulatory

• FDA-regulated drug study