A Study on the Effect of AB-106 on the Pharmacokinetics of Digoxin

NCT05357911 | Completed Phase 1

• 1 other identifier: AB-106-C111
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• The PK exposure parameters of digoxin

  Area under the plasma concentration versus time curve (AUC)

  17 days

Secondary Outcomes (8)

• The PK parameters of digoxin

  17 days

• The PK parameters of digoxin

  17 days

• The PK parameters of digoxin

  17 days

• The PK parameters of digoxin

  17 days

• The PK parameters of digoxin

  17 days

Study Arms (1)

digoxin cohort

EXPERIMENTAL

Drug: AB-106, digoxin

Interventions

AB-106, digoxin DRUG

Period 1, single dose of 0.25mg digoxin; Period 2, Coadministrate AB-106 600mg and 0.25mg digoxin

digoxin cohort

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nuvation Bio Inc.: lead
• AnHeart Therapeutics Inc.: collaborator

Study Sites (1)

Shanghai Xuhui Central Hospital

Shanghai, China

Location

MeSH Terms

Interventions

Digoxin

Intervention Hierarchy (Ancestors)

Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates

Study Officials

• Shuangmiao Wang

  AnHeart Therapeutics Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: May 3, 2022
• Study Start: July 13, 2021
• Primary Completion: August 20, 2021
• Study Completion: December 3, 2021
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)