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- Klinische proef NCT02339207
First in Human Study of AL-335; Single Dose, Food Effect in Healthy Volunteers; Multiple Doses in Chronic Hepatitis C Genotype 1
15 oktober 2019 bijgewerkt door: Alios Biopharma Inc.
A Randomized, Double-blind, Placebo-controlled, First-in-human, 3 Part Study of Orally Administered AL-335 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Dosing and Food-effect in Healthy Volunteers, and Multiple Ascending Dosing in Subjects With Chronic Hepatitis C Genotype 1 Infection
This randomized, double-blind, placebo-controlled, 3-part study will assess the safety, tolerability, and pharmacokinetics of orally administered AL-335 in healthy volunteers (HV) and subjects with CHC infection.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
112
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
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Brittany
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Rennes, Brittany, Frankrijk, 355042
- Biotrial
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Tbilisi, Georgië
- Arensia, Research Institute of Clinical Medicine
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Chisinau, Moldavië, Republiek
- Arensia, Republican Clinical Hospital
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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 60 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Subject has provided written consent.
- In the investigator's opinion, the subject is able to understand and comply with protocol requirements, instructions, and protocol stated restrictions and is likely to complete the study as planned.
- Subject is in good health as deemed by the investigator, based on the findings of a medical evaluation including medical history, physical examination, laboratory tests, and ECG.
- Male or female, 18-60 years of age for HV and 18-65 years of age for subjects with CHC.
- Body mass index (BMI) 18-32 kg/m2, inclusive, for HV and 18-35 kg/m2, inclusive, for subjects with CHC. The minimum weight is 50 kg in both populations. No more than 25% of patients in any cohort may be enrolled with a BMI ≥ 30 kg/m2.
- A female subject is eligible to participate in this study if she is of non childbearing potential (defined as females with a documented tubal ligation, bilateral oophorectomy, or hysterectomy) or postmenopausal (defined as 12 months of spontaneous amenorrhea and follicle stimulating hormone (FSH) level within the laboratory's reference range for postmenopausal females). A post-menopausal female receiving hormone replacement therapy who is willing to discontinue hormone therapy 28 days before study drug dosing and agrees to remain off hormone replacement therapy for the duration of the study may be eligible for study participation.
- If male, subject is surgically sterile or practicing specific forms of birth control (as outline in Section 6.2.9) until 90 days after the end of the study.
Additional inclusion criteria for subjects with CHC infection:
- Documentation of Genotype 1 HCV infection for greater than 6 months at dosing
- Screening HCV RNA viral load ≥ 105 IU/mL using a sensitive quantitative assay, such as COBAS® Taqman® HCV Test 2.0
Exclusion Criteria:
- Clinically significant cardiovascular, respiratory, renal, gastrointestinal, hematologic, neurologic, thyroid, or any other medical illness or psychiatric disorder, as determined by the Investigator and/or Sponsor's Medical Monitor.
- Positive test for HAV IgM, HBsAg, or HIV Ab. In Parts 1 and 2 positive HCV serology is exclusionary.
- Any condition that, in the opinion of the investigator, would compromise the study's objectives or the well-being of the subject or prevent the subject from meeting the study requirements.
- Participation in an investigational drug trial or having received an investigational vaccine within 30 days or 5 half lives (whichever is longer) prior to study medication.
- Clinically significant abnormal ECG findings. Particularly, a history or family history of prolonged QT syndrome (e.g., torsade de pointes) or sudden cardiac death; or a corrected QT interval (QTc) > 450 milliseconds for male subjects and >470 milliseconds for female subjects at the Screening Visit.
- Clinically significant blood loss or elective blood donation of significant volume (i.e., > 500 mL) within 60 days of first dose of study drug; > 1 unit of plasma within 7 days of first dose of study drug.
- Abnormal heart rate, respiratory rate, temperature or blood pressure values outside of the normal range (evaluated in a semi-recumbent or recumbent position after 5 minutes of rest). One repeat measurement after an additional 5 minutes of rest is permitted.
- Evidence of active infection (other than CHC infection in subjects enrolled in Part 3).
- Unwilling to abstain from alcohol for 48 hours prior to the start of dosing through the study completion visit.
- History of regular alcohol intake > 7 units per week of alcohol for females and > 14 units per week for males (one unit is defined as 10 g alcohol) within 3 months of screening visit.
- For healthy subjects (Parts 1-2), history of regular use of tobacco (i.e., ≥10 cigarettes per day) or nicotine-containing products within 3 months of the screening visit. For subjects with CHC infection, history of regular use of tobacco- or nicotine-containing products is allowed.
- The subject has a positive pre-study drug screen. A minimum list of drugs that will be screened for includes amphetamines, barbiturates, cocaine, opiates, cannabinoids, phencyclidine (PCP) and benzodiazepines. Subjects with CHC may be included if they have a positive result for cannabinoids at screening. However, they must be willing to abstain from cannabinoid use throughout the duration of the study.
- In Parts 1-2, the use of concomitant medications, including prescription, over the counter medications, or herbal medications within 14 days prior to the first dose of study medication is excluded, unless approved by the Sponsor's Medical Monitor. PRN use of a nonsteroidal anti inflammatory drug (NSAID) is permitted.
- For subjects in Part 3, the use of prescription and over the counter medications deemed necessary to maintain the health status of the subject are permitted, if approved by the Sponsor's Medical Monitor. PRN NSAID use is permitted. Further guidance for the use of prior medication in subjects with CHC can be found in Section 5.7.
- Subjects must not have received any drug known to be a strong inducer or inhibitor of CYP450 enzymes within 2 weeks prior to study drug dosing (Appendix C).
- Exposure to more than four new investigational entities within 12 months prior to the first dosing day.
Abnormal biochemistry or hematology laboratory results obtained at screening. Elevated bilirubin in subjects with suspected Gilbert's disease is allowed.
Additional exclusion criteria for subjects with CHC infection:
- History of clinical hepatic decompensation, e.g., variceal bleeding, spontaneous bacterial peritonitis, ascites, hepatic encephalopathy or active jaundice
- Liver biopsy within two years or Fibroscan evaluation within 6 months prior to randomization that demonstrates cirrhosis (Knodell score >3, Metavir score > 3, Ishak score > 4). Fibroscan liver stiffness score > 10.5 kPa.
- Prior treatment for CHC
- Serum alanine aminotransferase (ALT) concentration >5 x ULN
- Alpha Fetoprotein (AFP) is ≥ ULN, unless the absence of a hepatic mass or lesion is demonstrated by ultrasound within the screening period.
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: Gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Placebo-vergelijker: Placebo
Placebo dosed once in human volunteers in increasing dosages or once daily for seven days in patients with chronic Hepatitis C in increasing dosages.
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Experimenteel: AL-335
AL-335 dosed once in human volunteers in increasing dosages or once daily for seven days in patients with chronic Hepatitis C in increasing dosages.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Safety Data: Number and frequency of treatment emergent adverse events, physical examination findings, abnormal vital signs, 12 lead ECG and abnormal clinical laboratory results
Tijdsspanne: From screening to Day 8 (SAD/FE) and Day 21 (MAD)
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Tabulation of the number and frequency of treatment emergent adverse events, physical examination findings, abnormal vital signs, 12 lead ECG and abnormal clinical laboratory results (including chemistry, hematology, and urine).
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From screening to Day 8 (SAD/FE) and Day 21 (MAD)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Single Dose PK: Cmax, tmax, t1/2, CL/F and Vz/F (for AL-335 only), AUC0-inf or AUClast
Tijdsspanne: From dosing to Day 8 visit for each SAD/FE cohort
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PK parameters of AL-335, and metabolites following single dose administration: Cmax, tmax, t1/2, CL/F and Vz/F (for AL-335 only), AUC0-inf or AUClast
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From dosing to Day 8 visit for each SAD/FE cohort
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Multiple Dose PK: Cmax, tmax, t1/2, AUClast and AUC0 tau
Tijdsspanne: From dosing to final study visit (21 days) for each cohort
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• PK parameters of AL-335, ALS-022399, ALS-022227 (and other metabolites if applicable) following repeat dose administration: Cmax, tmax, t1/2, AUClast and AUC0 tau
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From dosing to final study visit (21 days) for each cohort
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Hepatitis C viral levels
Tijdsspanne: From screening to final study visit (21 days) for each cohort
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HCV ribonucleic acid (RNA) viral load change from baseline to final study visit in subjects with CHC infection
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From screening to final study visit (21 days) for each cohort
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
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)
31 december 2014
Primaire voltooiing (Werkelijk)
31 mei 2016
Studie voltooiing (Werkelijk)
31 mei 2016
Studieregistratiedata
Eerst ingediend
18 december 2014
Eerst ingediend dat voldeed aan de QC-criteria
14 januari 2015
Eerst geplaatst (Schatting)
15 januari 2015
Updates van studierecords
Laatste update geplaatst (Werkelijk)
16 oktober 2019
Laatste update ingediend die voldeed aan QC-criteria
15 oktober 2019
Laatst geverifieerd
1 oktober 2019
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het spijsverteringsstelsel
- RNA-virusinfecties
- Virusziekten
- Infecties
- Door bloed overgedragen infecties
- Overdraagbare ziekten
- Lever Ziekten
- Flaviviridae-infecties
- Hepatitis, viraal, menselijk
- Enterovirusinfecties
- Picornaviridae-infecties
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis, chronisch
- Hepatitis C, chronisch
- Anti-infectieuze middelen
- Antivirale middelen
- Adafosbuvir
Andere studie-ID-nummers
- AL-335-601
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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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