- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05357911
A Study on the Effect of AB-106 on the Pharmacokinetics of Digoxin
May 5, 2022 updated by: AnHeart Therapeutics Inc.
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)
Study Overview
Study Type
Interventional
Enrollment (Actual)
16
Phase
- 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 Locations
-
-
-
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
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
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: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: digoxin cohort
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Period 1, single dose of 0.25mg digoxin; Period 2, Coadministrate AB-106 600mg and 0.25mg digoxin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The PK exposure parameters of digoxin
Time Frame: 17 days
|
Area under the plasma concentration versus time curve (AUC)
|
17 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The PK parameters of digoxin
Time Frame: 17 days
|
Peak Plasma Concentration (Cmax)
|
17 days
|
The PK parameters of digoxin
Time Frame: 17 days
|
Time to drug peak plasma concentration (Tmax)
|
17 days
|
The PK parameters of digoxin
Time Frame: 17 days
|
Percentage of area under the curve from time of the last quantifiable concentration to infinity to area under the curve to infinity (AUC_extr%)
|
17 days
|
The PK parameters of digoxin
Time Frame: 17 days
|
Lambda_z, first-order rate constant associated with the terminal portion of the curve (λz)
|
17 days
|
The PK parameters of digoxin
Time Frame: 17 days
|
Terminal phase elimination half life (t1/2)
|
17 days
|
The PK parameters of digoxin
Time Frame: 17 days
|
Apparent total clearance (CL/F), Vz/F
|
17 days
|
The PK parameters of digoxin
Time Frame: 17 days
|
Apparent volume of distribution (Vz/F)
|
17 days
|
Safety assessment
Time Frame: 35 days
|
Adverse events (AEs)
|
35 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Shuangmiao Wang, 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)
July 13, 2021
Primary Completion (ACTUAL)
August 20, 2021
Study Completion (ACTUAL)
December 3, 2021
Study Registration Dates
First Submitted
July 9, 2021
First Submitted That Met QC Criteria
April 27, 2022
First Posted (ACTUAL)
May 3, 2022
Study Record Updates
Last Update Posted (ACTUAL)
May 6, 2022
Last Update Submitted That Met QC Criteria
May 5, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AB-106-C111
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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