ALT-801 DDI Study in Healthy Volunteers
Phase 1
Completed
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Interventions
- Registration Number
- NCT04972396
- Lead Sponsor
- Altimmune, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Male or female healthy volunteers, age 18 to 55 years, inclusive
- Body mass index (BMI) 25.0- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1 ALT-801 - Part 3 Ethinylestradiol and Levonorgestrel - Part 1 Metformin - Part 2 Warfarin - Part 1 Atorvastatin - Part 2 Digoxin - Part 3 ALT-801 - Part 2 ALT-801 -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Cmax and Tmax of metformin and atorvastatin/warfarin and digoxin Day 36 The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs) Up to Day 77 Cmax and Tmax of ethinylestradiol and levonorgestrel Day 43
Trial Locations
- Locations (2)
Q-Pharm
🇦🇺Herston, Queensland, Australia
CMAX Clinical Research
🇦🇺Adelaide, South Australia, Australia