Study the Effect of Omeprazole on AB-106 Pharmacokinetics

November 19, 2024 updated by: Nuvation Bio Inc.

A Phase I, Single-center, Open-label, Fixed Sequence Study in Chinese Healthy Male Adults to Evaluate the Effect of Omeprazole on the Pharmacokinetics of AB-106

This is a single-center, open-label, fixed sequence phase I clinical study. To evaluate the effect of continuous administration of omeprazole magnesium enteric coated tablets on PK after single dose AB-106 capsule administration in Chinese healthy male subjects. This study includes a screening period (1-28 days before administration), treatment period (34 days), and follow-up period ( after the last dose completed 7 ± 3 days). The treatment period of this study was divided into two periods, and the subjects were divided into two groups, 12 subjects in the first group and 10 subjects in the second group. The treatment method and research process of each group of subjects are the same. After the first group of subjects completes the second cycle and is evaluated by the investigator and sponsor, the second group of subjects can start administration. If there are no more than 4 subjects in the first group who have vomiting gastrointestinal reaction (vomiting occurs within 8 hours after each cycle of administration) after completing the two cycles of administration of AB-106 400 mg, they can be added to the second group of subjects, and the number of added subjects shall not exceed the number of subjects who have vomiting gastrointestinal reaction. If more than 4 subjects have gastrointestinal reaction of vomiting, the investigator and sponsor will make a comprehensive evaluation, and can reduce the dosage of AB-106 to 200 mg, and 22 subjects will be included in the trial at one time or supplemented in the second group to complete the 400 mg dose group

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Shanghai, China
        • Shanghai Xuhui Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 51 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 between 18 and 55 years old (including the threshold).
  3. When screening, the body weight was more than 50 kg, and the body mass index (BMI) was between 19 and 26 kg/m2 (including the cut-off value).
  4. Subjects voluntarily signed the Informed Consent Form (ICF).
  5. Subjects can communicate well with researchers and complete the study according to the protocol.
  6. Male subjects with fertility agree that they and their sexual partners must take effective contraceptive measures during the study period and within 90 days after the last dose, and agree not to donate sperm during this period.

Exclusion Criteria:

  1. Evidence or medical history (including drug allergy) of hematology, kidney, endocrine, lung, gastrointestinal, cardiovascular, liver, spirit, nerve or allergic diseases with clinical significance according to the judgment of the investigator.
  2. According to the judgment of the researcher, abnormal laboratory tests with clinical significance (blood routine test, blood biochemical test [fasting], urine routine test, blood coagulation function test).
  3. Systolic blood pressure<90 mmHg or ≥ 140 mmHg, diastolic blood pressure<50 mmHg or ≥ 90 mmHg, and the abnormality judged by the investigator is clinically significant.
  4. People with eye diseases or people with a history of eye diseases who are considered by the investigator to increase the risk of the subject through eye examination.
  5. 12 lead ECG showed QTcF>450 ms (msec) or QRS interval>120 msec.
  6. Fever history within 5 days before administration.
  7. People with positive detection of hepatitis B virus surface antigen (HBs Ag), hepatitis C virus antibody (HCV Ab), human immunodeficiency virus (HIV) antibody, or Treponema pallidum (TP) antibody.
  8. The food or drug known to be used 28 days before screening is a powerful inhibitor of cytochrome P450 3A4 enzyme (CYP3A4); Known for use 28 days before screening Its drug is CYP3A4 potent inducer; The drug used 28 days before screening and during the study was CYP3A4 substrate with a narrow therapeutic window.
  9. The food or drug known to be used 28 days before screening is the substrate of P-gp
  10. Take Chinese herbal supplements within 28 days before screening; Take any clinical study drug within 3 months or 5 half lives (whichever is longer) before screening; Prescription drugs or over-the-counter drugs and dietary supplements were used within 14 days or 5 half lives (whichever is longer) before screening. As an exception, acetaminophen/paracetamol can be used in a dose of 1 g/day.
  11. Those who have been vaccinated with live vaccine or attenuated vaccine within 28 days before the start of the trial.
  12. Subjects were unwilling to stop the intake of caffeinated or purine containing foods (such as coffee, tea, cola, chocolate) in each administration cycle from 48 hours before the first administration to the end of the last PK sample collection.
  13. The alcohol intake is more than 14 units/week (1 unit of alcohol is equivalent to 360 mL of beer, 150 mL of wine, or 45 mL of Baijiu), or the subject is unwilling to stop drinking alcohol in each administration cycle, from 48 hours before the first administration to the end of the last PK sample collection, or the alcohol breath test is positive.
  14. Smoking ≥ 5 cigarettes a day, or the subject is unwilling/unable to stop nicotine intake in each dosing cycle from 48 hours before the first dosing to the end of the last PK sample collection.
  15. Major surgery was performed within 6 months before administration.
  16. Blood donation or blood loss ≥ 400 mL within 3 months before administration, or ≥ 200 mL within 1 month before administration
  17. Suffer from gastrointestinal, liver, kidney diseases or other diseases or sequelae known to interfere with drug absorption, distribution, metabolism or excretion within 3 months before the screening period and during the screening period. A history of sensitivity to heparin or heparin induced thrombocytopenia.
  18. Those who have a history of drug abuse or used soft drugs (such as marijuana) or hard drugs (such as heroin, cocaine, etc.) within one year before the study and during the study, or who are positive in drug screening.
  19. Those who are unwilling or unable to comply with the lifestyle guidelines described in this program.
  20. Staff of any institution affiliated to the clinical center and their immediate family members. Immediate relatives refer to those who are related by blood or law, including spouses, children, parents, brothers and sisters.
  21. The researcher judged that it was not suitable to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Omeprazole combined with AB-106 group
Drug: Multiple administration of omeprazole Single administration of AB-106
Take 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: Day 1 to day15 for both treatment cycle one and cycle two, the total duration is 30 days
plasma drug peak concentration
Day 1 to day15 for both treatment cycle one and cycle two, the total duration is 30 days
AUClast
Time Frame: 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
Day 1 to day15 for both treatment cycle one and cycle two, the total duration is 30 days
AUCinf
Time Frame: 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)
Day 1 to day15 for both treatment cycle one and cycle two, the total duration is 30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Tmax
Time Frame: Day 1 to day15 for both treatment cycle one and cycle two, the total duration is 30 days
Time to reach plasma drug peak concentration
Day 1 to day15 for both treatment cycle one and cycle two, the total duration is 30 days
λ z
Time Frame: Day 1 to day15 for both treatment cycle one and cycle two, the total duration is 30 days
Elimination rate constant
Day 1 to day15 for both treatment cycle one and cycle two, the total duration is 30 days
t1/2
Time Frame: Day 1 to day15 for both treatment cycle one and cycle two, the total duration is 30 days
elimination half-life
Day 1 to day15 for both treatment cycle one and cycle two, the total duration is 30 days
CL/F
Time Frame: Day 1 to day15 for both treatment cycle one and cycle two, the total duration is 30 days
Apparent clearance
Day 1 to day15 for both treatment cycle one and cycle two, the total duration is 30 days
Vz/F
Time Frame: Day 1 to day15 for both treatment cycle one and cycle two, the total duration is 30 days
apparent distribution volume
Day 1 to day15 for both treatment cycle one and cycle two, the total duration is 30 days
Number of adverse events as assessed by CTCAE 5.0
Time Frame: Screening period (1-28 days before treatment), treatment period (34 days) and follow-up period (7 ± 3 days after the last visit). The total duration is about 69 days.
Number of participants with treatment-related or not-related adverse events as assessed by CTCAE v5.0
Screening period (1-28 days before treatment), treatment period (34 days) and follow-up period (7 ± 3 days after the last visit). The total duration is about 69 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nuvation Bio Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
AnHeart Therapeutics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 2, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 20, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 20, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 26, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AB-106-C114

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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