ALT-801 DDI Study in Healthy Volunteers

• Status: Not yet recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Altimmune, Inc.
• Treatments: Atorvastatin; Digoxin; Ethinyl Estradiol; Levonorgestrel; Metformin; Warfarin

Criteria

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