Pemvidutide (ALT-801) DDI Study in Healthy Volunteers

June 18, 2025 updated by: Altimmune, Inc.

An Open-label Study of the Effect of ALT-801 on the Pharmacokinetics of Metformin, Warfarin, Atorvastatin, Digoxin, and the Combined Oral Contraceptive Ethinylestradiol/Levonorgestrel in Healthy Volunteers

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Brisbane, Australia
        • Nucleus Network
    • South Australia
      • Adelaide, South Australia, Australia
        • CMAX Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1 Metformin and Atorvastatin with and without Pemvidutide

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: Metformin
Taken by mouth (PO)
Drug: Atorvastatin
Taken by mouth (PO)
Drug: Pemvidutide
Injected subcutaneously (SC)
Other Names:
  • ALT-801
Experimental: Part 2 Warfarin and Digoxin with and without Pemvidutide

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: Warfarin
Taken by mouth (PO)
Drug: Digoxin
Taken by mouth (PO)
Drug: Pemvidutide
Injected subcutaneously (SC)
Other Names:
  • ALT-801
Experimental: Part 3 Ethinylestradiol and Levonorgestrel with and without Pemvidutide

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: Ethinylestradiol and Levonorgestrel
Taken by mouth (PO)
Drug: Pemvidutide
Injected subcutaneously (SC)
Other Names:
  • ALT-801

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Baseline and Day 43

Secondary Outcome Measures

Outcome Measure
Time Frame
Cmax and Tmax of metformin and atorvastatin/warfarin and digoxin
Time Frame: Day 36
Day 36
Cmax and Tmax of ethinylestradiol and levonorgestrel
Time Frame: Day 43
Day 43
The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Up to Day 77
Up to Day 77

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Altimmune, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2021

Primary Completion (Actual)

May 15, 2022

Study Completion (Actual)

May 15, 2022

Study Registration Dates

First Submitted

July 14, 2021

First Submitted That Met QC Criteria

July 14, 2021

First Posted (Actual)

July 22, 2021

Study Record Updates

Last Update Posted (Actual)

June 24, 2025

Last Update Submitted That Met QC Criteria

June 18, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALT-801-103
  • Pemvidutide (Other Identifier: Altimmune)
  • ALT-801 (Other Identifier: Altimmune)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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