Recent Updates
Recently added Catalysts

Multiple administration of omeprazole Single administration of AB-106

Phase 1

Undisclosed | Small molecule | Other |Nuvation Bio Inc.|Trials Updated: Nov 21, 2024

Multiple administration of omeprazole Single administration of AB-106 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Nov 2022

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Multiple administration of omeprazole Single administration of AB-106 clinical trials

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
Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about Multiple administration of omeprazole Single administration of AB-106

What is AB-106?

AB-106 is an investigational small molecule developed by Nuvation Bio Inc. (ticker NUVB). It has been studied in a Phase 1 pharmacokinetic trial in healthy male volunteers in China. The trial evaluated how omeprazole affects the pharmacokinetics of AB-106.

Who is developing AB-106?

AB-106 is being developed by Nuvation Bio Inc., which trades under the ticker NUVB. The company sponsored the Phase 1 pharmacokinetic study of AB-106 conducted in China.

What phase is AB-106 in?

AB-106 is in Phase 1 clinical development. One Phase 1 pharmacokinetic trial has been completed, and no active trials are currently listed. The study enrolled 24 healthy male volunteers.

What clinical trials is AB-106 in?

AB-106 has been evaluated in one completed Phase 1 trial, NCT05609929, titled Study the Effect of Omeprazole on AB-106 Pharmacokinetics. The trial enrolled 24 healthy male volunteers in China and was an uncontrolled, non-randomized pharmacokinetic study.

What is AB-106 used for?

AB-106 is an investigational drug and no therapeutic indication has been disclosed. Its only recorded clinical study was a Phase 1 pharmacokinetic trial examining the effect of omeprazole on AB-106 in healthy volunteers, not a study in patients with a specific disease.

How does omeprazole affect AB-106?

The completed Phase 1 trial NCT05609929 was designed to study the effect of omeprazole on the pharmacokinetics of AB-106. The study enrolled 24 healthy male volunteers in China and has been completed, evaluating drug interaction between the two agents.