Clinical Trials Logo

Clinical Trial Summary

This is a Phase 1, open-label, drug-drug interaction (DDI) study of ALT-801 under steady state conditions on concomitantly administered medications in healthy subjects. The study will evaluate the effect of ALT-801 on the pharmacokinetics (PK) of metformin, warfarin, atorvastatin, digoxin, and the combined oral contraceptive (OC) 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 ALT-801 administration and the second is with ALT-801 at steady state.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms

  • Fatty Liver
  • NASH - Nonalcoholic Steatohepatitis
  • Non-alcoholic Fatty Liver Disease

NCT number NCT04972396
Study type Interventional
Source Altimmune, Inc.
Contact
Status Completed
Phase Phase 1
Start date October 5, 2021
Completion date May 15, 2022

See also
  Status Clinical Trial Phase
Completed NCT03289897 - Non-invasive Rapid Assessment of NAFLD Using Magnetic Resonance Imaging With LiverMultiScan N/A
Active, not recruiting NCT05479721 - LITMUS Imaging Study
Not yet recruiting NCT05120557 - Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH N/A
Recruiting NCT04976283 - Effect of Oral Anti-diabetic Medication on Liver Fat in Subjects With Type II Diabetes and Non-alcoholic Fatty Liver Phase 4
Completed NCT02784444 - A Study to Evaluate the Safety, Tolerability & Efficacy of MSDC-0602K in Patients With NASH Phase 2
Not yet recruiting NCT05499949 - The Franciscus Obesity NASH Study
Completed NCT04321343 - Study of PXL065 in Patients With Nonalcoholic Steatohepatitis (NASH) Phase 2
Recruiting NCT04371042 - PROtocol of Metabolic and Cryptogenic livEr Disease regisTry for intEgration of Omic Studies
Not yet recruiting NCT03648554 - Researching an Effect of GLP-1 Agonist on Liver STeatosis (REALIST) Phase 4
Completed NCT03748628 - Absorption, Metabolism and Excretion (AME) Study of [14C]EDP-305 in Healthy Male Subjects Phase 1
Enrolling by invitation NCT05195944 - Semaglutide vs Sitagliptin Phase 4
Completed NCT04643795 - Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Multiple Oral Doses of MGL-3196 in Subjects With Varying Degrees of Hepatic Impairment and Healthy Matched Control Subjects Phase 1
Terminated NCT03669133 - Vitamin E for NASH Treatment in HIV Infected Individuals Phase 2
Completed NCT04066400 - Role of a Wheat Containing Diet on Non-alcoholic Steatohepatitis N/A
Completed NCT03536650 - Effect of DMR in the Treatment of NASH N/A
Completed NCT03783897 - A Drug-drug Interaction Study to Investigate the Effect of Coadministration of EDP-305 on the PK of a Combined Oral Contraceptive in Healthy Female Subjects Phase 1
Completed NCT04618744 - A Study to Assess the Safety and Efficacy of Oral Insulin in T2DM Patients With Nonalcoholic Steatohepatitis (NASH) Phase 2
Active, not recruiting NCT05338034 - Phase 2a Study of HPG1860 in Subjects With NASH Phase 2
Active, not recruiting NCT04653103 - NASH in Subjects With Different Classes of Obesity
Completed NCT04173065 - A Study to Assess the Efficacy and Safety of VK2809 for 52 Weeks in Subjects With Biopsy Proven NASH Phase 2