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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04972396




Registration number
NCT04972396
Ethics application status
Date submitted
14/07/2021
Date registered
22/07/2021
Date last updated
8/12/2022

Titles & IDs
Public title
ALT-801 DDI Study in Healthy Volunteers
Scientific 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
Secondary ID [1] 0 0
ALT-801-103
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
NASH - Nonalcoholic Steatohepatitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ALT-801
Treatment: Drugs - Metformin
Treatment: Drugs - Atorvastatin
Treatment: Drugs - Warfarin
Treatment: Drugs - Digoxin
Treatment: Drugs - Ethinylestradiol and Levonorgestrel

Experimental: Part 1 -

Experimental: Part 2 -

Experimental: Part 3 -


Treatment: Drugs: ALT-801
Injected subcutaneously (SC)

Treatment: Drugs: Metformin
Taken by mouth (PO)

Treatment: Drugs: Atorvastatin
Taken by mouth (PO)

Treatment: Drugs: Warfarin
Taken by mouth (PO)

Treatment: Drugs: Digoxin
Taken by mouth (PO)

Treatment: Drugs: Ethinylestradiol and Levonorgestrel
Taken by mouth (PO)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area Under the Plasma Concentration Versus Time Curve (AUC) of metformin and atorvastatin/warfarin and digoxin in presence of steady state ALT-801
Timepoint [1] 0 0
Baseline and Day 36
Primary outcome [2] 0 0
Area Under the Plasma Concentration Versus Time Curve (AUC) of ethinylestradiol and levonorgestrel in presence of steady state ALT-801
Timepoint [2] 0 0
Baseline and Day 43
Secondary outcome [1] 0 0
Cmax and Tmax of metformin and atorvastatin/warfarin and digoxin
Timepoint [1] 0 0
Day 36
Secondary outcome [2] 0 0
Cmax and Tmax of ethinylestradiol and levonorgestrel
Timepoint [2] 0 0
Day 43
Secondary outcome [3] 0 0
The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)
Timepoint [3] 0 0
Up to Day 77

Eligibility
Key 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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/05/2022
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
QLD,SA
Recruitment hospital [1] 0 0
Q-Pharm - Herston
Recruitment hospital [2] 0 0
CMAX Clinical Research - Adelaide
Recruitment postcode(s) [1] 0 0
- Herston
Recruitment postcode(s) [2] 0 0
- Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Altimmune, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04972396
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04972396