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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

2020年11月17日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

28

段階

  • フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~50年 (大人)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:基礎科学
  • 割り当て:ランダム化
  • 介入モデル:クロスオーバー割り当て
  • マスキング:トリプル

武器と介入

参加者グループ / アーム
介入・治療
実験的: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
実験的: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
実験的: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
実験的: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
実験的: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
実験的: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
実験的: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
実験的: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
実験的: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
実験的: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
経口錠剤
実験的: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
実験的: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
実験的: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

この研究は何を測定していますか?

主要な結果の測定

結果測定
時間枠
Parts 1, 2, and 3: Number of participants with any treatment-emergent serious adverse event (TESAE)
時間枠: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)
時間枠:up to 33 weeks
up to 33 weeks
Parts 1, 2, and 3: Number of participants with abnormal, clinically significant physical examination findings
時間枠:up to 33 weeks
up to 33 weeks
Parts 1, 2, and 3: Number of participants with abnormal, clinically significant safety laboratory test findings
時間枠:up to 33 weeks
up to 33 weeks
Parts 1, 2, and 3: Number of participants with abnormal, clinically significant vital sign values
時間枠:up to 33 weeks
up to 33 weeks
Parts 1, 2, and 3: Number of participants with abnormal, clinically significant electrocardiogram findings
時間枠:up to 33 weeks
up to 33 weeks
Parts 1 and 2: Plasma concentration of BOS172722
時間枠: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
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2018年3月21日

一次修了 (実際)

2018年10月9日

研究の完了 (実際)

2018年10月10日

試験登録日

最初に提出

2018年3月7日

QC基準を満たした最初の提出物

2018年3月7日

最初の投稿 (実際)

2018年3月13日

学習記録の更新

投稿された最後の更新 (実際)

2020年11月18日

QC基準を満たした最後の更新が送信されました

2020年11月17日

最終確認日

2020年11月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • BOS172767-01
  • 2017-004002-18 (EudraCT番号)
  • QCL118174 (その他の識別子:Quotient Study Number)

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

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