drugset / Trial / NCT04972396
Pemvidutide (ALT-801) DDI Study in Healthy Volunteers
RandomizedParallel-groupOpen-labelOther
Summary
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.
Timeline
- Start
- 2021-09-15
- Primary completion
- 2022-05-15
- Completion
- 2022-05-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atorvastatin | Small molecule | 40 mg | Oral |
| Subject | Digoxin | Other / unclassified | 0.5 mg | Oral |
| Subject | Levonorgestrel | Small molecule | 0.15 mg | Oral |
| Subject | Metformin | Small molecule | 500 mg | Oral |
| Subject | Pemvidutide | Unknown | 1.8 mg | Subcutaneous |
| Subject | Warfarin | Small molecule | 10 mg | Oral |
| Subject | ethinyl estradiol | Small molecule | 0.03 mg | Oral |