Pharmacokinetic StudyPhase 1NCT05609929
Study the Effect of Omeprazole on AB-106 Pharmacokinetics
A Phase 1 study testing Multiple administration of omeprazole Single administration of AB-106 in people with Pharmacokinetic Study, run by Nuvation Bio Inc. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetic Study
- What is being tested?
- Multiple administration of omeprazole Single administration of AB-106
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 2 Nov 2022to 20 Jan 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
- The age at the time of signing the informed consent was between 18 and 55 years old (including the threshold).
- 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).
- Subjects voluntarily signed the Informed Consent Form (ICF).
- Subjects can communicate well with researchers and complete the study according to the protocol.
- 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.
Who cannot join
- 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.
- 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).
- 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.
- 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.
- 12 lead ECG showed QTcF>450 ms (msec) or QRS interval>120 msec.
- Fever history within 5 days before administration.
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- 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.
- 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.
- The food or drug known to be used 28 days before screening is the substrate of P-gp
- 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.
- Those who have been vaccinated with live vaccine or attenuated vaccine within 28 days before the start of the trial.
- 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.
- 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.
- 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.
- Major surgery was performed within 6 months before administration.
- Blood donation or blood loss ≥ 400 mL within 3 months before administration, or ≥ 200 mL within 1 month before administration
- 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.
- 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.
- Those who are unwilling or unable to comply with the lifestyle guidelines described in this program.
- 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.
- The researcher judged that it was not suitable to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Pharmacokinetic Study
- Being tested
- Multiple administration of omeprazole Single administration of AB-106
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple administration of omeprazole Single administration of AB-106Drug
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
| Study group | Role | What they receive |
|---|---|---|
| Omeprazole combined with AB-106 group | Experimental | Not described Receives: Drug: Multiple administration of omeprazole Single administration of AB-106 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
plasma drug peak concentration
Measured: Day 1 to day15 for both treatment cycle one and cycle two, the total duration is 30 days
AUClast
area under the plasma drug concentration time curve from 0 to the last measurable drug concentration time point
Measured: Day 1 to day15 for both treatment cycle one and cycle two, the total duration is 30 days
AUCinf
Area under the plasma drug concentration time curve from 0 to infinity (if it can be calculated reliably)
Measured: Day 1 to day15 for both treatment cycle one and cycle two, the total duration is 30 days
Secondary outcomes (6)
Tmax
Time to reach plasma drug peak concentration
Measured: Day 1 to day15 for both treatment cycle one and cycle two, the total duration is 30 days
λ z
Elimination rate constant
Measured: Day 1 to day15 for both treatment cycle one and cycle two, the total duration is 30 days
t1/2
elimination half-life
Measured: Day 1 to day15 for both treatment cycle one and cycle two, the total duration is 30 days
CL/F
Apparent clearance
Measured: Day 1 to day15 for both treatment cycle one and cycle two, the total duration is 30 days
Vz/F
apparent distribution volume
Measured: 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
Number of participants with treatment-related or not-related adverse events as assessed by CTCAE v5.0
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start2 Nov 2022
- Primary completion20 Jan 2023
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacokinetic StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuvation Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AnHeart Therapeutics Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05609929
- Sponsor's protocol ID
- AB-106-C114
- Status last verified
- Nov 2024
- First submitted
- 26 Oct 2022
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05609929
- Acronym / sponsor ID
- AB-106-C114
- Conditions
- Pharmacokinetic Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Nuvation Bio Inc.Industry (pharma, biotech, devices)
- Collaborators
- AnHeart Therapeutics Inc.
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 8 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omeprazole combined with AB-106 group | Experimental | Drug: Multiple administration of omeprazole Single administration of AB-106 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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).
- The age at the time of signing the informed consent was between 18 and 55 years old (including the threshold).
- 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).
- Subjects voluntarily signed the Informed Consent Form (ICF).
- Subjects can communicate well with researchers and complete the study according to the protocol.
Key exclusion criteria (21 listed)
- 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.
- 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).
- 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.
- 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.
- 12 lead ECG showed QTcF>450 ms (msec) or QRS interval>120 msec.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiple administration of omeprazole Single administration of AB-106Take 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 | Drug | Omeprazole combined with AB-106 group |
Primary outcome
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
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
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)
6 secondary outcomes
Tmax
Time frame: 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
t1/2
Time frame: 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
Vz/F
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Multiple administration of omeprazole Single administration of AB-106 in people with Pharmacokinetic Study, run by Nuvation Bio Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: Day 1 to day15 for both treatment cycle one and cycle two, the total duration is 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.