ALT-801 DDI Study in Healthy Volunteers

Altimmune

Status and phase: Completed; Phase 1

Conditions: NASH - Nonalcoholic Steatohepatitis

Treatments: Drug: Ethinylestradiol and Levonorgestrel; Drug: ALT-801; Drug: Metformin; Drug: Digoxin; Drug: Warfarin; Drug: Atorvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT04972396

ALT-801-103

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 3 patient groups

Part 1

Experimental group

Treatment:

Drug: ALT-801

Drug: Metformin

Drug: Atorvastatin

Part 2

Experimental group

Treatment:

Drug: Warfarin

Drug: ALT-801

Drug: Digoxin

Part 3

Experimental group

Treatment:

Drug: ALT-801

Drug: Ethinylestradiol and Levonorgestrel