Solid TumorPhase 1NCT05357820
A Study of AB-106 in Chinese Healthy Adult Men Evaluated the Effects of Itraconazole and Rifampicin on AB-106 PK
A Phase 1 study testing AB-106, Itraconazole and AB-106, Rifampicin in people with Solid Tumor, run by Nuvation Bio Inc. at 1 site in China.
Trial summary
AB-106-C110 is China-only study, for investigating the drug interaction between AB-106 and CYP3A4 inhibitor (Itraconazole)/CYP3A4 inducer (Rifampin)（n=56） 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
- Solid Tumor
- What is being tested?
- AB-106, Itraconazole and AB-106, Rifampicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 19 Jul 2021to 3 Dec 2021
- 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
- The subject is willing to give written informed consent.
- The subject is capable to communicate well with investigator and comply with comply with protocol throughout the study.
- Aged between 18 to 55 at giving written informed consent.
- Chinese male healthy subjects (No clinical abnormality by medical history query, physical examination, vital signs, 12 lead ECG and clinical laboratory test)
- Body weight greater than 50.0 kg, and body mass index between 19 and 26 kg/m2, inclusive.
- For fertile males, agree to use effective contraception methods during the study intervention period and for at least 90 days after the last dose of investigational drug, and agree not to donate sperm during this period.
Who cannot join
- Any presence or history of clinically significant hematology, nephrology, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, mental, neurological, or allergic diseases (including drug allergy, but not including untreated, asymptomatic seasonal allergies when administered).
- Any clinically significant laboratory abnormality (hematology, biochemistry [fasting], coagulation, thyroid function, urinalysis.)
- systolic blood pressure (SBP) < 90 mmHg or ≥140 mmHg, diastolic blood pressure (DBP) < 50 mmHg or ≥ 90 mmHg, and clinically significant abnormality based on the judgment of investigators
- Any presence or history of eye disease in whom the risk is increased by the participation to the study or treatment with investigational drug in the opinion of the investigator, such as glaucoma, retinal detachment, vitreous turbidity, and moths.
- The 12-lead ECG showed QTcF > 450 milliseconds (msec) or QRS interval > 120 msec. If QTcF exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times, and the average of 3 QTcF or QRS values should be used to determine subject's eligibility.
- Fever within 5 days before the administration.
Show all 20Show fewer
- Active hepatitis B virus (HBV) surface antigen, hepatitis C virus antibody (HCV Ab), human immunodeficiency virus (HIV) or treponema pallidum (TP) antibody
- Within 28 days prior to the first dose of study treatment, use of food or drugs that are known potent CYP3A4 inhibitors including (but not limited to) atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, aceto-eandomycin, voriconazole, grapefruit, grapefruit juice, grapefruit, citrus fruits or grapes Pomelo mixed species; or potent CYP3A4 inducers including (but not limited to) carbamazepine, phenobarbital, phenytoin, rifabutin, and rifampin and St. John's wort; or CYP3A4 substrates with narrow therapeutic window including (but not limited to)dihydroergotamine, ergotamine, pimozide, astemizole, cisapride, and terfenadine.
- Chinese herbal medicine or tonic must be withdrawn at least 28 days prior to the first dose of study treatment; Any clinical study drug is prohibited within 3 months or 5 half-lives prior to the first dose of investigational drug; Any prescription/over-the-counter drug/dietary supplement is prohibited within 14 days or 5 half-lives prior to the first dose of investigational drug; as an exception, acetaminophen/paracetamol can be used at a dose of 1 g/day.
- Vaccinated with live or attenuated vaccine within 28 days prior to the first dose of study treatment
- Subject is unwilling to withdraw foods containing caffeine or purines (such as coffee, tea, cola, chocolate) from 48h before first dose to finishing the last PK sample collection.
- Alcohol intake is greater than 14 units/week (1 unit of alcohol is equivalent to 360 mL of beer, or 150 mL of wine, or 45 mL of baijiu), or subject is unwilling to withdraw alcohol from 48h before first dose to finishing the last PK sample collection.
- Smoking more than 5 cigarette per day, or subject is unwilling to withdraw nicotine from 48h before first dose to finishing the last PK sample collection.
- Any drug abuse, or taking any soft drug (such as marijuana) or hard drugs (heroin, cocaine, etc.) from 1 year before and during the study period.
- Any significant surgical history within 6 months prior to the first dose of study treatment.
- Blood donation or blood loss ≥ 400 mL within 3 months or ≥ 200 mL within 1 month prior to the first dose of study treatment.
- Presence of gastrointestinal, liver, kidney disease or other diseases or sequelae that are known to interfere with drug absorption, distribution, metabolism, or excretion. With a history of sensitivity to heparin or heparin-induced thrombocytopenia
- Unwilling or incapable to follow the lifestyle standard described in the protocol.
- Staff members of any institution affiliated with the clinical site and their immediate family members. Immediate family members refer to persons with blood or legal relationship, including spouses, children, parents, and siblings.
- Ineligible to participate in the study based on the judgement of investigators
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single-center, Open-label, Fixed-sequence Study of AB-106 in Chinese Healthy Adult Men Evaluated the Effects of Itraconazole and Rifampicin on AB-106 Pharmacokinetics
AB-106-C110 is China-only study, for investigating the drug interaction between AB-106 and CYP3A4 inhibitor (Itraconazole)/CYP3A4 inducer (Rifampin)（n=56）
- Conditions
- Solid Tumor
- Being tested
- AB-106, Itraconazole, AB-106, Rifampicin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AB-106, ItraconazoleDrug
single dose AB-106 at Day1, Itraconazole QD at Day14~Day28, single dose AB-106 at Day17
AB-106, RifampicinDrug
single dose AB-106 at Day1, Itraconazole QD at Day14~Day32, single dose AB-106 at Day21
| Study group | Role | What they receive |
|---|---|---|
| Itraconazole cohort | Experimental | Not described Receives: Drug: AB-106, Itraconazole |
| Rifampicin cohort | Experimental | Not described Receives: Drug: AB-106, Rifampicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
AB-106 PK Exposure Parameters
Peak Plasma Concentration (Cmax)
Measured: 29 days
AB-106 PK Exposure Parameters
Area under the plasma concentration versus time curve (AUC)
Measured: 29 days
Secondary outcomes (7)
AB-106 PK Parameters
Time to drug peak plasma concentration (Tmax)
Measured: 29 days
AB-106 PK Parameters
Percentage of area under the curve from time of the last quantifiable concentration to infinity to area under the curve to infinity (AUC_extr%)
Measured: 29 days
AB-106 PK Parameters
Lambda_z, first-order rate constant associated with the terminal portion of the curve (λz)
Measured: 29 days
AB-106 PK Parameters
Terminal phase elimination half life (t1/2)
Measured: 29 days
AB-106 PK Parameters
Apparent total clearance (CL/F)
Measured: 29 days
AB-106 PK Parameters
Apparent volume of distribution (Vz/F)
Measured: 29 days
Safety Assessment
Adverse events (AEs)
Measured: 47 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start19 Jul 2021
- Primary completion3 Dec 2021
- Study completion3 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuvation Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357820
- Sponsor's protocol ID
- AB-106-C110
- Status last verified
- Apr 2022
- First submitted
- 9 Jul 2021
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 of AB-106 in Chinese Healthy Adult Men Evaluated the Effects of Itraconazole and Rifampicin on AB-106 Pharmacokinetics
- ClinicalTrials.gov ID
- NCT05357820
- Acronym / sponsor ID
- AB-106-C110
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Nuvation Bio Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 3 Dec 2021 (actual)
- Study completion
- 3 Dec 2021 (actual)
- First posted
- 3 May 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.
AB-106-C110 is China-only study, for investigating the drug interaction between AB-106 and CYP3A4 inhibitor (Itraconazole)/CYP3A4 inducer (Rifampin)（n=56）
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Itraconazole cohort | Experimental | Drug: AB-106, Itraconazole |
| Rifampicin cohort | Experimental | Drug: AB-106, Rifampicin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- The subject is willing to give written informed consent.
- The subject is capable to communicate well with investigator and comply with comply with protocol throughout the study.
- Aged between 18 to 55 at giving written informed consent.
- Chinese male healthy subjects (No clinical abnormality by medical history query, physical examination, vital signs, 12 lead ECG and clinical laboratory test)
- Body weight greater than 50.0 kg, and body mass index between 19 and 26 kg/m2, inclusive.
Key exclusion criteria (20 listed)
- Any presence or history of clinically significant hematology, nephrology, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, mental, neurological, or allergic diseases (including drug allergy, but not including untreated, asymptomatic seasonal allergies when administered).
- Any clinically significant laboratory abnormality (hematology, biochemistry [fasting], coagulation, thyroid function, urinalysis.)
- systolic blood pressure (SBP) < 90 mmHg or ≥140 mmHg, diastolic blood pressure (DBP) < 50 mmHg or ≥ 90 mmHg, and clinically significant abnormality based on the judgment of investigators
- Any presence or history of eye disease in whom the risk is increased by the participation to the study or treatment with investigational drug in the opinion of the investigator, such as glaucoma, retinal detachment, vitreous turbidity, and moths.
- The 12-lead ECG showed QTcF > 450 milliseconds (msec) or QRS interval > 120 msec. If QTcF exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times, and the average of 3 QTcF or QRS values should be used to determine subject's eligibility.
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 |
|---|---|---|
| AB-106, Itraconazolesingle dose AB-106 at Day1, Itraconazole QD at Day14~Day28, single dose AB-106 at Day17 | Drug | Itraconazole cohort |
| AB-106, Rifampicinsingle dose AB-106 at Day1, Itraconazole QD at Day14~Day32, single dose AB-106 at Day21 | Drug | Rifampicin cohort |
Primary outcome
AB-106 PK Exposure Parameters
Time frame: 29 days
Peak Plasma Concentration (Cmax)
AB-106 PK Exposure Parameters
Time frame: 29 days
Area under the plasma concentration versus time curve (AUC)
7 secondary outcomes
AB-106 PK Parameters
Time frame: 29 days
AB-106 PK Parameters
Time frame: 29 days
AB-106 PK Parameters
Time frame: 29 days
AB-106 PK Parameters
Time frame: 29 days
AB-106 PK Parameters
Time frame: 29 days
AB-106 PK Parameters
Time frame: 29 days
Safety Assessment
Time frame: 47 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.
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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 AB-106, Itraconazole and AB-106, Rifampicin in people with Solid Tumor, 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 20 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?
AB-106 PK Exposure Parameters (time frame: 29 days). The study lists 2 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.