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Pemvidutide (ALT-801) DDI Study in Healthy Volunteers

NCT04972396 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-06-24

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Altimmune, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-15
Primary Completion
2022-05-15
Completion
2022-05-15
FDA Drug
Yes

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04972396 on ClinicalTrials.gov