ALT-801 DDI Study in Healthy Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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NASH - Nonalcoholic Steatohepatitis

Intervention / Treatment
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* Drug: ALT-801
* Drug: Metformin
* Drug: Atorvastatin
* Drug: Warfarin
* Drug: Digoxin
* Drug: Ethinylestradiol and Levonorgestrel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1<br> | Drug: ALT-801<br>* Injected subcutaneously (SC)<br>Drug: Metformin<br>* Taken by mouth (PO)<br>Drug: Atorvastatin<br>* Taken by mouth (PO)<br>|
| Experimental: Part 2<br> | Drug: ALT-801<br>* Injected subcutaneously (SC)<br>Drug: Warfarin<br>* Taken by mouth (PO)<br>Drug: Digoxin<br>* Taken by mouth (PO)<br>|
| Experimental: Part 3<br> | Drug: ALT-801<br>* Injected subcutaneously (SC)<br>Drug: Ethinylestradiol and Levonorgestrel<br>* Taken by mouth (PO)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax and Tmax of metformin and atorvastatin/warfarin and digoxin |  | Day 36 | 
| Cmax and Tmax of ethinylestradiol and levonorgestrel |  | Day 43 | 
| The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs) |  | Up to Day 77 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NASH