Pemvidutide (ALT-801) DDI Study in Healthy Volunteers

Sponsor
Altimmune, Inc.
Study ID
NCT04972396
Phase
PHASE1
Status
Completed

Conditions

  • NASH - Nonalcoholic Steatohepatitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Pemvidutide — DRUG
    Injected subcutaneously (SC)
  • Metformin — DRUG
    Taken by mouth (PO)
  • Atorvastatin — DRUG
    Taken by mouth (PO)
  • Warfarin — DRUG
    Taken by mouth (PO)
  • Digoxin — DRUG
    Taken by mouth (PO)
  • Ethinylestradiol and Levonorgestrel — DRUG
    Taken by mouth (PO)

Study Details

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.

Key Dates

Start date
Sep 15, 2021
Status verified
Jun 2025
Primary completion
May 15, 2022
Completion
May 15, 2022

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • 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.

Primary Outcome Measure

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 ]

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