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A Study of AB-106 in Chinese Healthy Adult Men Evaluated the Effects of Itraconazole and Rifampicin on AB-106 PK

27 april 2022 bijgewerkt door: AnHeart Therapeutics Inc.

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)

Studie Overzicht

Studietype

Ingrijpend

Inschrijving (Werkelijk)

56

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

      • Beijing, China
        • Xuanwu Hospital of Capital Medical University

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 55 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Mannelijk

Beschrijving

Inclusion Criteria:

  1. The subject is willing to give written informed consent.
  2. The subject is capable to communicate well with investigator and comply with comply with protocol throughout the study.
  3. Aged between 18 to 55 at giving written informed consent.
  4. Chinese male healthy subjects (No clinical abnormality by medical history query, physical examination, vital signs, 12 lead ECG and clinical laboratory test)
  5. Body weight greater than 50.0 kg, and body mass index between 19 and 26 kg/m2, inclusive.
  6. 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:

  1. 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).
  2. Any clinically significant laboratory abnormality (hematology, biochemistry [fasting], coagulation, thyroid function, urinalysis.)
  3. 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
  4. 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.
  5. 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.
  6. Fever within 5 days before the administration.
  7. Active hepatitis B virus (HBV) surface antigen, hepatitis C virus antibody (HCV Ab), human immunodeficiency virus (HIV) or treponema pallidum (TP) antibody
  8. 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.
  9. 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.
  10. Vaccinated with live or attenuated vaccine within 28 days prior to the first dose of study treatment
  11. 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.
  12. 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.
  13. 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.
  14. 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.
  15. Any significant surgical history within 6 months prior to the first dose of study treatment.
  16. Blood donation or blood loss ≥ 400 mL within 3 months or ≥ 200 mL within 1 month prior to the first dose of study treatment.
  17. 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
  18. Unwilling or incapable to follow the lifestyle standard described in the protocol.
  19. 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.
  20. Ineligible to participate in the study based on the judgement of investigators

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Itraconazole cohort
single dose AB-106 at Day1, Itraconazole QD at Day14~Day28, single dose AB-106 at Day17
Experimenteel: Rifampicin cohort
single dose AB-106 at Day1, Itraconazole QD at Day14~Day32, single dose AB-106 at Day21

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
AB-106 PK Exposure Parameters
Tijdsspanne: 29 days
Peak Plasma Concentration (Cmax)
29 days
AB-106 PK Exposure Parameters
Tijdsspanne: 29 days
Area under the plasma concentration versus time curve (AUC)
29 days

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
AB-106 PK Parameters
Tijdsspanne: 29 days
Time to drug peak plasma concentration (Tmax)
29 days
AB-106 PK Parameters
Tijdsspanne: 29 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%)
29 days
AB-106 PK Parameters
Tijdsspanne: 29 days
Lambda_z, first-order rate constant associated with the terminal portion of the curve (λz)
29 days
AB-106 PK Parameters
Tijdsspanne: 29 days
Terminal phase elimination half life (t1/2)
29 days
AB-106 PK Parameters
Tijdsspanne: 29 days
Apparent total clearance (CL/F)
29 days
AB-106 PK Parameters
Tijdsspanne: 29 days
Apparent volume of distribution (Vz/F)
29 days
Safety Assessment
Tijdsspanne: 47 days
Adverse events (AEs)
47 days

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

19 juli 2021

Primaire voltooiing (Werkelijk)

3 december 2021

Studie voltooiing (Werkelijk)

3 december 2021

Studieregistratiedata

Eerst ingediend

9 juli 2021

Eerst ingediend dat voldeed aan de QC-criteria

27 april 2022

Eerst geplaatst (Werkelijk)

3 mei 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 mei 2022

Laatste update ingediend die voldeed aan QC-criteria

27 april 2022

Laatst geverifieerd

1 april 2022

Meer informatie

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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