Pemvidutide (ALT-801) DDI Study in Healthy Volunteers

NCT04972396 | Completed Phase 1 FDA Drug

• 3 other identifiers: ALT-801-103PemvidutideALT-801
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

NASH

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Cmax and Tmax of metformin and atorvastatin/warfarin and digoxin

  Day 36

• Cmax and Tmax of ethinylestradiol and levonorgestrel

  Day 43

• The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)

  Up to Day 77

Study Arms (3)

Part 1 Metformin and Atorvastatin with and without Pemvidutide

EXPERIMENTAL

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.

Drug: Pemvidutide; Drug: Metformin; Drug: Atorvastatin

Part 2 Warfarin and Digoxin with and without Pemvidutide

EXPERIMENTAL

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.

Drug: Pemvidutide; Drug: Warfarin; Drug: Digoxin

Part 3 Ethinylestradiol and Levonorgestrel with and without Pemvidutide

EXPERIMENTAL

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.

Drug: Pemvidutide; Drug: Ethinylestradiol and Levonorgestrel

Interventions

Pemvidutide DRUG

Injected subcutaneously (SC)

Also known as: ALT-801

Part 1 Metformin and Atorvastatin with and without Pemvidutide; Part 2 Warfarin and Digoxin with and without Pemvidutide; Part 3 Ethinylestradiol and Levonorgestrel with and without Pemvidutide

Metformin DRUG

Taken by mouth (PO)

Part 1 Metformin and Atorvastatin with and without Pemvidutide

Atorvastatin DRUG

Taken by mouth (PO)

Part 1 Metformin and Atorvastatin with and without Pemvidutide

Warfarin DRUG

Taken by mouth (PO)

Part 2 Warfarin and Digoxin with and without Pemvidutide

Digoxin DRUG

Taken by mouth (PO)

Part 2 Warfarin and Digoxin with and without Pemvidutide

Ethinylestradiol and Levonorgestrel DRUG

Taken by mouth (PO)

Part 3 Ethinylestradiol and Levonorgestrel with and without Pemvidutide

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Altimmune, Inc.: lead

Study Sites (2)

CMAX Clinical Research

Adelaide, South Australia, Australia

Location

Nucleus Network

Brisbane, Australia

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

ALT-801; Metformin; Atorvastatin; Warfarin; Digoxin; Ethinyl Estradiol; Levonorgestrel

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates; Norpregnatrienes; Norpregnanes; Norsteroids; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Norgestrel; Norpregnenes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: July 22, 2021
• Study Start: September 15, 2021
• Primary Completion: May 15, 2022
• Study Completion: May 15, 2022
• Last Updated: June 24, 2025

Record last verified: 2025-06

Locations

AU (2)