Back to resultsALT-801 DDI Study in Healthy Volunteers
Primary Purpose
NASH - Nonalcoholic Steatohepatitis
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
ALT-801
Metformin
Atorvastatin
Warfarin
Digoxin
Ethinylestradiol and Levonorgestrel
Sponsored by
About this trial
This is an interventional other trial for NASH - Nonalcoholic Steatohepatitis focused on measuring NASH
Eligibility 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
Sites / Locations
- Q-Pharm
- CMAX Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Part 1
Part 2
Part 3
Arm Description
Outcomes
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
Area Under the Plasma Concentration Versus Time Curve (AUC) of ethinylestradiol and levonorgestrel in presence of steady state ALT-801
Secondary Outcome Measures
Cmax and Tmax of metformin and atorvastatin/warfarin and digoxin
Cmax and Tmax of ethinylestradiol and levonorgestrel
The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04972396
Brief Title
ALT-801 DDI Study in Healthy Volunteers
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 5, 2021 (Actual)
Primary Completion Date
May 15, 2022 (Actual)
Study Completion Date
May 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Altimmune, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NASH - Nonalcoholic Steatohepatitis
Keywords
NASH
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part 1
Arm Type
Experimental
Arm Title
Part 2
Arm Type
Experimental
Arm Title
Part 3
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ALT-801
Intervention Description
Injected subcutaneously (SC)
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Taken by mouth (PO)
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
Taken by mouth (PO)
Intervention Type
Drug
Intervention Name(s)
Warfarin
Intervention Description
Taken by mouth (PO)
Intervention Type
Drug
Intervention Name(s)
Digoxin
Intervention Description
Taken by mouth (PO)
Intervention Type
Drug
Intervention Name(s)
Ethinylestradiol and Levonorgestrel
Intervention Description
Taken by mouth (PO)
Primary Outcome Measure Information:
Title
Area Under the Plasma Concentration Versus Time Curve (AUC) of metformin and atorvastatin/warfarin and digoxin in presence of steady state ALT-801
Time Frame
Baseline and Day 36
Title
Area Under the Plasma Concentration Versus Time Curve (AUC) of ethinylestradiol and levonorgestrel in presence of steady state ALT-801
Time Frame
Baseline and Day 43
Secondary Outcome Measure Information:
Title
Cmax and Tmax of metformin and atorvastatin/warfarin and digoxin
Time Frame
Day 36
Title
Cmax and Tmax of ethinylestradiol and levonorgestrel
Time Frame
Day 43
Title
The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)
Time Frame
Up to Day 77
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Q-Pharm
City
Herston
State/Province
Queensland
Country
Australia
Facility Name
CMAX Clinical Research
City
Adelaide
State/Province
South Australia
Country
Australia
12. IPD Sharing Statement
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ALT-801 DDI Study in Healthy Volunteers
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