The purpose of this study is to test a new medicine called Inno8. The study will test how eating and drinking before and after taking Inno8 affects how well it is absorbed in the stomach. The study consists of four arms. Participants will take the study medicine after an overnight fast. How long participants will need to fast depends on which group participants are in. After taking the study medicine, participants will need to fast again. The study will last for up to 9.5 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
NNC0442-0344 A will be administered orally.
Altasciences Clinical LA, Inc.
Cypress, California, United States
RECRUITINGAUC0-∞: the area under the plasma Inno8 concentration-time curve from time 0 to infinity after a single oral dose
Measured as nanograms\*day per millilitre (ng\*day/mL).
Time frame: From baseline (Day 1) to day 17
Cmax: Maximum observed plasma Inno8 concentration after a single oral dose
Measured as nanograms per millilitre (ng/mL).
Time frame: From baseline (Day 1) to day 17
Tmax: The time to maximum observed plasma Inno8 concentration after a single oral dose
Measured as hours.
Time frame: From baseline (Day 1) to day 17
Number of treatment emergent adverse events
Measured as count of events.
Time frame: From time of dosing (Day 1) to day 36
Change in D-dimer
Measured as absolute (ng/mL) and percentage (%).
Time frame: From baseline (Day 1) to day 36
Change in prothrombin fragment 1 and 2
Measured as absolute \[(picomoles per litre) pmol/L\] and %.
Time frame: From baseline (Day 1) to day 36
Change in fibrinogen
Measured as absolute \[(milligrams per decilitre) mg/dL\] and %.
Time frame: From baseline (Day 1) to day 36
Change in platelets
Measured as absolute \[(ten to the ninth power per litre) 10\^9/L\] and %.
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Time frame: From baseline (Day 1) to day 36
Change in FIX antigen
Measured as %.
Time frame: From baseline (Day 1) to day 36
Change in FX antigen
Measured as %.
Time frame: From baseline (Day 1) to day 36