Solid TumorPhase 1NCT05357911
A Study on the Effect of AB-106 on the Pharmacokinetics of Digoxin
A Phase 1 study testing AB-106, digoxin in people with Solid Tumor, run by Nuvation Bio Inc. at 1 site in China.
Trial summary
AB-106-C111 is China-only study, for investigating the drug interaction between AB-106 and P-gp substrate (Digoxin). （n=16） 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, digoxin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 13 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
- Chinese male healthy subjects (No clinical abnormality by medical history query, physical examination, vital signs, 12 lead ECG and clinical laboratory test)
- Aged between 18 to 55 at giving written informed consent.
- Body weight greater than 50.0 kg, and body mass index between 19 and 26 kg/m2, inclusive.
- 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.
- 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).
- Any clinically significant laboratory abnormality (hematology, biochemistry [fasting], 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.
- Fever within 5 days before the administration.
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- 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.
- Within 28 days prior to the first dose of study treatment, use of food or drugs that are known p-gp substrates including (but not limited to) amiodarone, carvedilol, clarithromycin, dronedarone, itraconazole, lapatinib, lopinavir and ritonavir, propafenone, quinidine, ranolazine, Tonavir, Saquinavir and Ritonavir, Trapevir, Telanavir and Ritonavir, Verapamil.
- 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 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
- 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.
- 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 in Chinese Healthy Male Adults to Evaluate the Effect of AB-106 on the Pharmacokinetics of Digoxin
AB-106-C111 is China-only study, for investigating the drug interaction between AB-106 and P-gp substrate (Digoxin). （n=16）
- Conditions
- Solid Tumor
- Being tested
- AB-106, digoxin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AB-106, digoxinDrug
Period 1, single dose of 0.25mg digoxin; Period 2, Coadministrate AB-106 600mg and 0.25mg digoxin
| Study group | Role | What they receive |
|---|---|---|
| digoxin cohort | Experimental | Not described Receives: Drug: AB-106, digoxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The PK exposure parameters of digoxin
Area under the plasma concentration versus time curve (AUC)
Measured: 17 days
Secondary outcomes (8)
The PK parameters of digoxin
Peak Plasma Concentration (Cmax)
Measured: 17 days
The PK parameters of digoxin
Time to drug peak plasma concentration (Tmax)
Measured: 17 days
The PK parameters of digoxin
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: 17 days
The PK parameters of digoxin
Lambda_z, first-order rate constant associated with the terminal portion of the curve (λz)
Measured: 17 days
The PK parameters of digoxin
Terminal phase elimination half life (t1/2)
Measured: 17 days
The PK parameters of digoxin
Apparent total clearance (CL/F), Vz/F
Measured: 17 days
The PK parameters of digoxin
Apparent volume of distribution (Vz/F)
Measured: 17 days
Safety assessment
Adverse events (AEs)
Measured: 35 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 start13 Jul 2021
- Primary completion20 Aug 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuvation Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AnHeart Therapeutics Inc.
- Responsible party
- Sponsor
- Investigators
- Shuangmiao Wang, Study director, AnHeart Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357911
- Sponsor's protocol ID
- AB-106-C111
- Status last verified
- Nov 2024
- 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
- Individual data sharing
- 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 in Chinese Healthy Male Adults to Evaluate the Effect of AB-106 on the Pharmacokinetics of Digoxin
- ClinicalTrials.gov ID
- NCT05357911
- Acronym / sponsor ID
- AB-106-C111
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Nuvation Bio Inc.Industry (pharma, biotech, devices)
- Collaborators
- AnHeart Therapeutics Inc.
- Study start
- 13 Jul 2021 (actual)
- Primary completion
- 20 Aug 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-C111 is China-only study, for investigating the drug interaction between AB-106 and P-gp substrate (Digoxin). （n=16）
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| digoxin cohort | Experimental | Drug: AB-106, digoxin |
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 (No clinical abnormality by medical history query, physical examination, vital signs, 12 lead ECG and clinical laboratory test)
- Aged between 18 to 55 at giving written informed consent.
- Body weight greater than 50.0 kg, and body mass index between 19 and 26 kg/m2, inclusive.
- 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.
Key exclusion criteria (21 listed)
- Any presence or history of clinically significant hematology, nephrology, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, mental, neurological, or allergic diseases (including drug allergy).
- Any clinically significant laboratory abnormality (hematology, biochemistry [fasting], 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.
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, digoxinPeriod 1, single dose of 0.25mg digoxin; Period 2, Coadministrate AB-106 600mg and 0.25mg digoxin | Drug | digoxin cohort |
Primary outcome
The PK exposure parameters of digoxin
Time frame: 17 days
Area under the plasma concentration versus time curve (AUC)
8 secondary outcomes
The PK parameters of digoxin
Time frame: 17 days
The PK parameters of digoxin
Time frame: 17 days
The PK parameters of digoxin
Time frame: 17 days
The PK parameters of digoxin
Time frame: 17 days
The PK parameters of digoxin
Time frame: 17 days
The PK parameters of digoxin
Time frame: 17 days
The PK parameters of digoxin
Time frame: 17 days
Safety assessment
Time frame: 35 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: No
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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.
Shuangmiao Wang study director
AnHeart Therapeutics Inc.
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, digoxin 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 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?
The PK exposure parameters of digoxin (time frame: 17 days). 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.