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Study to Determine the Single and Repeat Dose Pharmacokinetics, Food Effect, Proton Pump Inhibitor (PPI) Drug Interaction, Safety and Tolerability of Oral Prototype Formulations of BOS172767 in Healthy Subjects

17. listopadu 2020 aktualizováno: Boston Pharmaceuticals

A Phase 1 Study to Determine the Single and Repeat Dose Pharmacokinetics, Food Effect, PPI Drug Interaction, Safety and Tolerability of Oral Prototype Formulations of BOS172767 in Healthy Subjects

Part 1 of the study will be conducted to provide additional information on the safety and tolerability of single doses of BOS172767 in healthy participants, to evaluate the pharmacokinetic (PK) profiles (including relative bioavailability) of BOS172767 following oral administration of 3 prototype formulations in healthy participants compared to an immediate release capsule formulation (reference), and also to determine the relative bioavailability of a selected BOS172767 prototype formulation in the fed and fasted states.

Part 2 of the study will be conducted to provide additional information on the safety and tolerability of escalating single doses of the selected formulation of BOS172767 in healthy participants, to evaluate the PK profile following increased single doses of the selected formulation of BOS172767 following administration in healthy participants, and also to evaluate the dose linearity of the selected prototype.

Part 3 of the study will be conducted to provide additional information on the safety, tolerability, and PK of the selected formulation of BOS172767 following multiple ascending doses (MADs) over 14 days of dosing in healthy participants.

Přehled studie

Detailní popis

Part 1 is comprised of a single-dose, part-randomized, open-label, 6-way crossover in 12 healthy participants. Participants will be dosed on 6 separate occasions (in 6 treatment periods), and will receive a single prototype of BOS172767 in each treatment period.

Part 2 is comprised of a single ascending dose, fixed-sequence, open-label, 3-way crossover with an optional fourth dosing period in 10 healthy participants. Participants will be dosed on 4 separate occasions (in 4 treatment periods), and will receive a single prototype of BOS172767 in each treatment period.

Part 3 is a double-blind (sponsor-open), placebo-controlled, randomized MAD part in 36 healthy participants (12 per study cohort). Participants will be dosed on 3 separate occasions (in 3 treatment periods), and will receive a single prototype of BOS172767 in each treatment period.

Parts 2 and 3 are contingent upon successful completion of Part 1.

Typ studie

Intervenční

Zápis (Aktuální)

28

Fáze

  • Fáze 1

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 50 let (Dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • Healthy males or healthy females of non-child bearing potential
  • Age 18 to 50 years of age at time of signing informed consent
  • Body mass index of 18.0 to 32.0 kilograms per meters squared (kg/m^2) at Screening, or, if outside the range, considered not clinically significant by the investigator
  • Must be willing and able to communicate and participate in the whole study
  • Must have a negative Quantiferon tuberculosis test at Screening
  • Must provide written informed consent
  • Must agree to use an adequate method of contraception

Exclusion Criteria:

  • Participants who have received any investigational medicinal product (IMP) in a clinical research study within the previous 3 months prior to dosing
  • Participants who are study site employees, or immediate family members of a study site or sponsor employee
  • Participants who have previously been enrolled (dosed) in this study
  • History of any drug or alcohol abuse in the past 2 years prior to Screening
  • Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 milliliters [mL] of 40% spirit or a 125 mL glass of wine)
  • Current smokers and those who have smoked within the last 12 months prior to Screening. A breath carbon monoxide reading of greater than 20 parts per million at Screening or admission
  • Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months prior to Screening
  • Females of childbearing potential
  • Participants who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at Screening
  • Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator
  • Confirmed positive drugs of abuse test result
  • Positive hepatitis B surface antigen, hepatitis C virus antibody or human immunodeficiency virus results
  • Evidence of renal impairment at Screening, as indicated by an estimated creatinine clearance of <70 mL/minute using the Cockcroft-Gault equation
  • History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease (including gall stones and/or cholecystectomy), neurological or psychiatric disorder, as judged by the investigator
  • Serious adverse reaction or serious hypersensitivity to any drug or the IMP formulation excipients
  • Adverse reaction to rabeprazole, its excipients or any proton pump inhibitors (Part 2 only)
  • Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active.
  • Donation or loss of greater than 400 mL of blood within the previous 3 months
  • Participants who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 grams per day paracetamol or hormone replacement therapy) or herbal remedies in the 14 days before IMP administration. Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as agreed by the Principal Investigator and sponsor's medical monitor.
  • Participants who have any ongoing fungal infections (stable toe nail onychomycosis is allowed)
  • Failure to satisfy the investigator of fitness to participate for any other reason

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Základní věda
  • Přidělení: Randomizované
  • Intervenční model: Crossover Assignment
  • Maskování: Trojnásobný

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Part 1: Regimen A
Participants will be treated with a BOS172767 200 milligram (mg) spray dried dispersion tablet (2 × 100 mg tablets) in the fasted state on Day 1.
Oral tablets
Experimentální: Part 1: Regimen B
Participants will be treated with a BOS172767 200 mg lipid capsule (2 × 100 mg capsules) in the fasted state on Day 1.
Oral capsules
Experimentální: Part 1: Regimen C
Participants will be treated with a BOS172767 200 mg micronized capsule (2 × 100 mg capsules) in the fasted state on Day 1.
Oral capsules
Experimentální: Part 1: Regimen D
Participants will be treated with a BOS172767 200 mg immediate release reference capsule formulation (2 × 100 mg capsules) in the fasted state on Day 1.
Oral capsules
Experimentální: Part 1: Regimen E
Participants will be treated with a selected dose of a prototype formulation of BOS172767 in the fasted state on Day 1.
Oral tablets
Oral capsules
Oral capsules
Oral capsules
Experimentální: Part 1: Regimen F
Participants will be treated with a selected dose of a prototype formulation of BOS172767 in the fed state on Day 1.
Oral tablets
Oral capsules
Oral capsules
Oral capsules
Experimentální: Part 2: Regimen G
Participants will be treated with 400 mg of the selected BOS172767 prototype in the fasted state on Day 1.
Oral tablets
Oral capsules
Oral capsules
Oral capsules
Experimentální: Part 2: Regimen H
Participants will be treated with 600 mg of the selected BOS172767 prototype in the fasted state on Day 1.
Oral tablets
Oral capsules
Oral capsules
Oral capsules
Experimentální: Part 2: Regimen I
Participants will be treated with 800 mg of the selected BOS172767 prototype in the fasted state on Day 1.
Oral tablets
Oral capsules
Oral capsules
Oral capsules
Experimentální: Part 2: Regimen J
Participants will be treated with rabeprazole on Days -3 to -1, and a selected dose of the BOS172767 prototype in the fasted state on Day 1.
Oral tablets
Oral capsules
Oral capsules
Oral capsules
Orální tablety
Experimentální: Part 3: Regimen K
Participants will be treated with 400 mg of a BOS172767 prototype or matching placebo once daily (QD) or twice daily (BID) for 14 days (Days 1 to 14).
Oral tablets
Oral capsules
Oral capsules
Oral capsules
Oral capsules
Oral tablets
Experimentální: Part 3: Regimen L
Participants will be treated with 600 mg of a BOS172767 prototype or matching placebo QD or BID for 14 days (Days 1 to 14).
Oral tablets
Oral capsules
Oral capsules
Oral capsules
Oral capsules
Oral tablets
Experimentální: Part 3: Regimen M
Participants will be treated with 800 mg of a BOS172767 prototype or matching placebo QD or BID for 14 days (Days 1 to 14).
Oral tablets
Oral capsules
Oral capsules
Oral capsules
Oral capsules
Oral tablets

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Časové okno
Parts 1, 2, and 3: Number of participants with any treatment-emergent serious adverse event (TESAE)
Časové okno: up to 33 weeks
up to 33 weeks
Parts 1, 2, and 3: Number of participants with any treatment-emergent non-serious adverse event (TEAE)
Časové okno: up to 33 weeks
up to 33 weeks
Parts 1, 2, and 3: Number of participants with abnormal, clinically significant physical examination findings
Časové okno: up to 33 weeks
up to 33 weeks
Parts 1, 2, and 3: Number of participants with abnormal, clinically significant safety laboratory test findings
Časové okno: up to 33 weeks
up to 33 weeks
Parts 1, 2, and 3: Number of participants with abnormal, clinically significant vital sign values
Časové okno: up to 33 weeks
up to 33 weeks
Parts 1, 2, and 3: Number of participants with abnormal, clinically significant electrocardiogram findings
Časové okno: up to 33 weeks
up to 33 weeks
Parts 1 and 2: Plasma concentration of BOS172722
Časové okno: predose; 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16 hours postdose (Day 1); 24 and 36 hours postdose (Day 2); 48 hours postdose (Day 3)
predose; 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16 hours postdose (Day 1); 24 and 36 hours postdose (Day 2); 48 hours postdose (Day 3)
Part 2 (Regimen I): Plasma concentration of BOS172722
Časové okno: admission to pre-dose (admission to dosing), 0 to 6 (Day 1), 6 to 12 (Day 1), 12 to 24 (Day 1), and 24 to 48 (Days 2 to 3) hours postdose
admission to pre-dose (admission to dosing), 0 to 6 (Day 1), 6 to 12 (Day 1), 12 to 24 (Day 1), and 24 to 48 (Days 2 to 3) hours postdose
Part 3: Plasma concentration of BOS172722
Časové okno: Days 1 and 7: pre-dose; 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours postdose. Days 4, 6, 9, 11, and 12: pre-dose. Day 14: pre-dose; 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, and 120 hours post-final dose
Days 1 and 7: pre-dose; 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours postdose. Days 4, 6, 9, 11, and 12: pre-dose. Day 14: pre-dose; 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, and 120 hours post-final dose
Part 3 (Regimen M): Plasma concentration of BOS172722
Časové okno: admission to pre-dose on Day 1; 0 to 6, 6 to 12, and 12 to 24 hours postdose on Days 1, 7, and 14
admission to pre-dose on Day 1; 0 to 6, 6 to 12, and 12 to 24 hours postdose on Days 1, 7, and 14

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

21. března 2018

Primární dokončení (Aktuální)

9. října 2018

Dokončení studie (Aktuální)

10. října 2018

Termíny zápisu do studia

První předloženo

7. března 2018

První předloženo, které splnilo kritéria kontroly kvality

7. března 2018

První zveřejněno (Aktuální)

13. března 2018

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

18. listopadu 2020

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

17. listopadu 2020

Naposledy ověřeno

1. listopadu 2020

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • BOS172767-01
  • 2017-004002-18 (Číslo EudraCT)
  • QCL118174 (Jiný identifikátor: Quotient Study Number)

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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