Study S001758

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

ClinicalTrials.gov record

Registration

Registration: NCT04972396
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 40
Start: 2021-09-15
Primary completion: 2022-05-15
Lead sponsor: Altimmune, Inc.
Conditions: NASH - Nonalcoholic Steatohepatitis
Interventions: DRUG:Pemvidutide; DRUG:Metformin; DRUG:Atorvastatin; DRUG:Warfarin; DRUG:Digoxin; DRUG:Ethinylestradiol and Levonorgestrel
Results posted: FALSE
Secondary identifiers: OTHER:Pemvidutide; OTHER:ALT-801

Registered 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 [Baseline and Day 36]
Area Under the Plasma Concentration Versus Time Curve (AUC) of ethinylestradiol and levonorgestrel in presence of steady state ALT-801 [Baseline and Day 43]

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