Pemvidutide (ALT-801) DDI Study in Healthy Volunteers

Altimmune, Inc.40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

NASH - Nonalcoholic Steatohepatitis

Interventions

PemvidutideDRUG

Injected subcutaneously (SC)

MetforminDRUG

Taken by mouth (PO)

AtorvastatinDRUG

Taken by mouth (PO)

Warfarin

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

CMAX Clinical Research

Adelaide, South Australia, Australia

Nucleus Network

Brisbane, Australia

Outcomes

Primary Outcomes

Area Under the Plasma Concentration Versus Time Curve (AUC) of metformin and atorvastatin/warfarin and digoxin in presence of steady state ALT-801

Time frame: Baseline and Day 36

Area Under the Plasma Concentration Versus Time Curve (AUC) of ethinylestradiol and levonorgestrel in presence of steady state ALT-801

Time frame: Baseline and Day 43

Secondary Outcomes

Cmax and Tmax of metformin and atorvastatin/warfarin and digoxin

Time frame: Day 36

Cmax and Tmax of ethinylestradiol and levonorgestrel

Time frame: Day 43

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

Time frame: Up to Day 77

Data from ClinicalTrials.gov

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