Pemvidutide (ALT-801) DDI Study in Healthy Volunteers

Status

Completed

Phase

Phase 1

Enrollment

40 participants (actual)

Sponsor

Altimmune, Inc. · Industry

Design

Randomized · Open label (no masking)

Countries

1 country

Australia

Start

15 Sept 2021

Primary completion

15 May 2022

Completion

15 May 2022

First posted

22 Jul 2021

Last update posted

24 Jun 2025

Conditions

NASH - Nonalcoholic Steatohepatitis

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.

• 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.

• 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.

• 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.

1. 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

2. 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

No study cites this trial.