ALT-801 DDI Study in Healthy Volunteers

Sponsor

Altimmune, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04972396

Collaborator

(none)

Enrollment

Locations

Arms

3.9

Anticipated Duration (Months)

Patients Per Site

4.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
NASH - Nonalcoholic Steatohepatitis	Drug: ALT-801 Drug: Metformin Drug: Atorvastatin Drug: Warfarin Drug: Digoxin Drug: Ethinylestradiol and Levonorgestrel	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Oct 5, 2021

Anticipated Primary Completion Date :

Feb 1, 2022

Anticipated Study Completion Date :

Feb 1, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Part 1

Drug: ALT-801

Injected subcutaneously (SC)

Drug: Metformin

Taken by mouth (PO)

Drug: Atorvastatin

Taken by mouth (PO)

Experimental: Part 2

Drug: ALT-801

Injected subcutaneously (SC)

Drug: Warfarin

Taken by mouth (PO)

Drug: Digoxin

Taken by mouth (PO)

Experimental: Part 3

Drug: ALT-801

Injected subcutaneously (SC)

Drug: Ethinylestradiol and Levonorgestrel

Taken by mouth (PO)

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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