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Multiple administration of omeprazole Single administration of AB-106

Phase 1

Pharmacokinetic Study | Small molecule | Other |Nuvation Bio Inc.|Last Updated: Nov 21, 2024

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

Multiple administration of omeprazole Single administration of AB-106 · 1 trial · 1 indication

Phase 1 1
NCT05609929Study the Effect of Omeprazole on AB-106 PharmacokineticsPharmacokinetic Study
COMPLETED24 Analytics
PHASE1COMPLETED
Study the Effect of Omeprazole on AB-106 Pharmacokinetics
Pharmacokinetic StudyUnlock trial analytics

Study Endpoints

Primary Endpoints

Cmax
Day 1 to day15 for both treatment cycle one and cycle two, the total duration is 30 days

plasma drug peak concentration

AUClast
Day 1 to day15 for both treatment cycle one and cycle two, the total duration is 30 days

area under the plasma drug concentration time curve from 0 to the last measurable drug concentration time point

AUCinf
Day 1 to day15 for both treatment cycle one and cycle two, the total duration is 30 days

Area under the plasma drug concentration time curve from 0 to infinity (if it can be calculated reliably)

Secondary Endpoints

Tmax
Day 1 to day15 for both treatment cycle one and cycle two, the total duration is 30 days
λ z
Day 1 to day15 for both treatment cycle one and cycle two, the total duration is 30 days
t1/2
Day 1 to day15 for both treatment cycle one and cycle two, the total duration is 30 days
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Omeprazole combined with AB-106 groupEXPERIMENTAL -

Interventions

NameTypeDescription
Multiple administration of omeprazole Single administration of AB-106DRUGTake AB-106 capsule 400 mg orally on an empty stomach in the morning of the first day of the first cycle Take omeprazole magnesium enteric coated tablets 40mg once a day, 30 minutes before breakfast on days 1-4 of the second cycle. On the morning of the fifth day of the second cycle, the subjects will take omeprazole magnesium enteric coated tablets 40 mg, and AB-106 capsules 400 mg after an interval of 1 hour
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Chinese male healthy subjects (health refers to the state without clinically relevant abnormalities confirmed by medical history, physical examination, vital signs, 12 lead ECG and clinical laboratory examination). 2. The age at the time of signing the informed consent was be...

Countries:China
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