Pemvidutide (ALT-801) DDI Study in Healthy Volunteers

Altimmune

Status and phase: Completed; Phase 1

Conditions: NASH - Nonalcoholic Steatohepatitis

Treatments: Drug: Digoxin; Drug: Warfarin; Drug: Pemvidutide; Drug: Ethinylestradiol and Levonorgestrel; Drug: Atorvastatin; Drug: Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT04972396

ALT-801 (Other Identifier)

Pemvidutide (Other Identifier)

ALT-801-103

Details and patient eligibility

About

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.

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) 28.0- 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 Metformin and Atorvastatin with and without Pemvidutide

Experimental group

Description:

In Period 1, subjects received metformin 500 mg BID on Days 1 and 2, single doses of metformin 500 mg and atorvastatin 40 mg on Day 3, and a single dose of pemvidutide 0.6 mg on Day 8. In Period 2, subjects received single doses of pemvidutide1.2 mg on Day 15 and 1.8 mg on Days 22 and 29, metformin 500 mg BID on Days 34 and 35, and pemvidutide 1.8 mg on Day 36 immediately followed by oral metformin 500 mg and atorvastatin 40 mg.

Treatment:

Drug: Metformin

Drug: Atorvastatin

Drug: Pemvidutide

Part 2 Warfarin and Digoxin with and without Pemvidutide

Experimental group

Description:

In Period 1, subjects received single doses of warfarin 10 mg and digoxin 500 mcg (0.5 mg) on Day 1, and a single dose of pemvidutide 0.6 mg on Day 8. In Period 2, subjects received single doses of pemvidutide 1.2 mg on Day 15 and 1.8 mg on Days 22 and 29, and pemvidutide1.8 mg immediately followed by warfarin 10 mg and digoxin 500 mcg (0.5 mg) on Day 36.

Treatment:

Drug: Pemvidutide

Drug: Warfarin

Drug: Digoxin

Part 3 Ethinylestradiol and Levonorgestrel with and without Pemvidutide

Experimental group

Description:

In Period 1, subjects received a combined oral contraceptive (COC) consisting of 0.03 mg ethinylestradiol and 0.15 mg levonorgestrel once daily on Days 1 through 9 and a single dose of pemvidutide 0.6 mg on Day 15. In Period 2, subjects received single doses of pemvidutide 1.2 mg on Day 22 and 1.8 mg on Days 29 and 36. Subjects also received COC once daily on Days 35 through 42 and a single dose of pemvidutide 1.8 mg followed immediately by a single dose of COC on Day 43.

Treatment:

Drug: Ethinylestradiol and Levonorgestrel

Drug: Pemvidutide