临床试验/NCT03464058

NCT03464058已完成1 期

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

Boston Pharmaceuticals1 个研究点分布在 1 个国家目标入组 28 人开始时间: 2018年3月21日最近更新: 2020年11月18日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Boston Pharmaceuticals
入组人数: 28
试验地点: 1
主要终点: Part 2 (Regimen I): Plasma concentration of BOS172722

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Basic Science
盲法: Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Part 1 and 2 of the study are open-label and therefore blinding is not required. Part 3 of the study is double-blind.

入排标准

年龄范围: 18 Years 至 50 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•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

排除标准

•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

研究组 & 干预措施

Part 2: Regimen H

Experimental

Participants will be treated with 600 mg of the selected BOS172767 prototype in the fasted state on Day 1.

干预措施: BOS172767 micronized capsules (Drug)

Part 1: Regimen A

Experimental

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.

干预措施: BOS172767 tablets (Drug)

Part 1: Regimen B

Experimental

Participants will be treated with a BOS172767 200 mg lipid capsule (2 × 100 mg capsules) in the fasted state on Day 1.

干预措施: BOS172767 liquid capsules (Drug)

Part 1: Regimen C

Experimental

Participants will be treated with a BOS172767 200 mg micronized capsule (2 × 100 mg capsules) in the fasted state on Day 1.

干预措施: BOS172767 micronized capsules (Drug)

Part 1: Regimen D

Experimental

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.

干预措施: BOS172767 immediate release capsules (Drug)

Part 1: Regimen E

Experimental

Participants will be treated with a selected dose of a prototype formulation of BOS172767 in the fasted state on Day 1.

干预措施: BOS172767 tablets (Drug)

Part 1: Regimen E

Experimental

Participants will be treated with a selected dose of a prototype formulation of BOS172767 in the fasted state on Day 1.

干预措施: BOS172767 liquid capsules (Drug)

Part 1: Regimen E

Experimental

Participants will be treated with a selected dose of a prototype formulation of BOS172767 in the fasted state on Day 1.

干预措施: BOS172767 micronized capsules (Drug)

Part 1: Regimen E

Experimental

Participants will be treated with a selected dose of a prototype formulation of BOS172767 in the fasted state on Day 1.

干预措施: BOS172767 immediate release capsules (Drug)

Part 1: Regimen F

Experimental

Participants will be treated with a selected dose of a prototype formulation of BOS172767 in the fed state on Day 1.

干预措施: BOS172767 tablets (Drug)

Part 1: Regimen F

Experimental

Participants will be treated with a selected dose of a prototype formulation of BOS172767 in the fed state on Day 1.

干预措施: BOS172767 liquid capsules (Drug)

Part 1: Regimen F

Experimental

Participants will be treated with a selected dose of a prototype formulation of BOS172767 in the fed state on Day 1.

干预措施: BOS172767 micronized capsules (Drug)

Part 1: Regimen F

Experimental

Participants will be treated with a selected dose of a prototype formulation of BOS172767 in the fed state on Day 1.

干预措施: BOS172767 immediate release capsules (Drug)

Part 2: Regimen G

Experimental

Participants will be treated with 400 mg of the selected BOS172767 prototype in the fasted state on Day 1.

干预措施: BOS172767 tablets (Drug)

Part 2: Regimen G

Experimental

Participants will be treated with 400 mg of the selected BOS172767 prototype in the fasted state on Day 1.

干预措施: BOS172767 liquid capsules (Drug)

Part 2: Regimen G

Experimental

Participants will be treated with 400 mg of the selected BOS172767 prototype in the fasted state on Day 1.

干预措施: BOS172767 micronized capsules (Drug)

Part 2: Regimen G

Experimental

Participants will be treated with 400 mg of the selected BOS172767 prototype in the fasted state on Day 1.

干预措施: BOS172767 immediate release capsules (Drug)

Part 2: Regimen H

Experimental

Participants will be treated with 600 mg of the selected BOS172767 prototype in the fasted state on Day 1.

干预措施: BOS172767 tablets (Drug)

Part 2: Regimen H

Experimental

Participants will be treated with 600 mg of the selected BOS172767 prototype in the fasted state on Day 1.

干预措施: BOS172767 liquid capsules (Drug)

Part 2: Regimen H

Experimental

Participants will be treated with 600 mg of the selected BOS172767 prototype in the fasted state on Day 1.

干预措施: BOS172767 immediate release capsules (Drug)

Part 2: Regimen I

Experimental

Participants will be treated with 800 mg of the selected BOS172767 prototype in the fasted state on Day 1.

干预措施: BOS172767 tablets (Drug)

Part 2: Regimen I

Experimental

Participants will be treated with 800 mg of the selected BOS172767 prototype in the fasted state on Day 1.

干预措施: BOS172767 liquid capsules (Drug)

Part 2: Regimen I

Experimental

Participants will be treated with 800 mg of the selected BOS172767 prototype in the fasted state on Day 1.

干预措施: BOS172767 micronized capsules (Drug)

Part 2: Regimen I

Experimental

Participants will be treated with 800 mg of the selected BOS172767 prototype in the fasted state on Day 1.

干预措施: BOS172767 immediate release capsules (Drug)

Part 2: Regimen J

Experimental

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.

干预措施: BOS172767 tablets (Drug)

Part 2: Regimen J

Experimental

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.

干预措施: BOS172767 liquid capsules (Drug)

Part 2: Regimen J

Experimental

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.

干预措施: BOS172767 micronized capsules (Drug)

Part 2: Regimen J

Experimental

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.

干预措施: BOS172767 immediate release capsules (Drug)

Part 2: Regimen J

Experimental

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.

干预措施: Rabeprazole (Drug)

Part 3: Regimen K

Experimental

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).

干预措施: BOS172767 tablets (Drug)

Part 3: Regimen K

Experimental

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).

干预措施: BOS172767 liquid capsules (Drug)

Part 3: Regimen K

Experimental

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).

干预措施: BOS172767 micronized capsules (Drug)

Part 3: Regimen K

Experimental

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).

干预措施: BOS172767 immediate release capsules (Drug)

Part 3: Regimen K

Experimental

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).

干预措施: BOS172767 matching placebo capsules (Drug)

Part 3: Regimen K

Experimental

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).

干预措施: BOS172767 matching placebo tablets (Drug)

Part 3: Regimen L

Experimental

Participants will be treated with 600 mg of a BOS172767 prototype or matching placebo QD or BID for 14 days (Days 1 to 14).

干预措施: BOS172767 tablets (Drug)

Part 3: Regimen L

Experimental

Participants will be treated with 600 mg of a BOS172767 prototype or matching placebo QD or BID for 14 days (Days 1 to 14).

干预措施: BOS172767 liquid capsules (Drug)

Part 3: Regimen L

Experimental

Participants will be treated with 600 mg of a BOS172767 prototype or matching placebo QD or BID for 14 days (Days 1 to 14).

干预措施: BOS172767 micronized capsules (Drug)

Part 3: Regimen L

Experimental

Participants will be treated with 600 mg of a BOS172767 prototype or matching placebo QD or BID for 14 days (Days 1 to 14).

干预措施: BOS172767 immediate release capsules (Drug)

Part 3: Regimen L

Experimental

Participants will be treated with 600 mg of a BOS172767 prototype or matching placebo QD or BID for 14 days (Days 1 to 14).

干预措施: BOS172767 matching placebo capsules (Drug)

Part 3: Regimen L

Experimental

Participants will be treated with 600 mg of a BOS172767 prototype or matching placebo QD or BID for 14 days (Days 1 to 14).

干预措施: BOS172767 matching placebo tablets (Drug)

Part 3: Regimen M

Experimental

Participants will be treated with 800 mg of a BOS172767 prototype or matching placebo QD or BID for 14 days (Days 1 to 14).

干预措施: BOS172767 tablets (Drug)

Part 3: Regimen M

Experimental

Participants will be treated with 800 mg of a BOS172767 prototype or matching placebo QD or BID for 14 days (Days 1 to 14).

干预措施: BOS172767 liquid capsules (Drug)

Part 3: Regimen M

Experimental

Participants will be treated with 800 mg of a BOS172767 prototype or matching placebo QD or BID for 14 days (Days 1 to 14).

干预措施: BOS172767 micronized capsules (Drug)

Part 3: Regimen M

Experimental

Participants will be treated with 800 mg of a BOS172767 prototype or matching placebo QD or BID for 14 days (Days 1 to 14).

干预措施: BOS172767 immediate release capsules (Drug)

Part 3: Regimen M

Experimental

Participants will be treated with 800 mg of a BOS172767 prototype or matching placebo QD or BID for 14 days (Days 1 to 14).

干预措施: BOS172767 matching placebo capsules (Drug)

Part 3: Regimen M

Experimental

Participants will be treated with 800 mg of a BOS172767 prototype or matching placebo QD or BID for 14 days (Days 1 to 14).

干预措施: BOS172767 matching placebo tablets (Drug)

结局指标

主要结局

Part 2 (Regimen I): Plasma concentration of BOS172722

时间窗: 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

Parts 1 and 2: Plasma concentration of BOS172722

时间窗: 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)

Parts 1, 2, and 3: Number of participants with any treatment-emergent serious adverse event (TESAE)

时间窗: up to 33 weeks

Parts 1, 2, and 3: Number of participants with any treatment-emergent non-serious adverse event (TEAE)

时间窗: up to 33 weeks

Parts 1, 2, and 3: Number of participants with abnormal, clinically significant physical examination findings

时间窗: up to 33 weeks

Parts 1, 2, and 3: Number of participants with abnormal, clinically significant vital sign values

时间窗: up to 33 weeks

Part 3: Plasma concentration of BOS172722

时间窗: 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

时间窗: 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

Parts 1, 2, and 3: Number of participants with abnormal, clinically significant safety laboratory test findings

时间窗: up to 33 weeks

Parts 1, 2, and 3: Number of participants with abnormal, clinically significant electrocardiogram findings

时间窗: up to 33 weeks

次要结局

未报告次要终点

研究者

发起方

Boston Pharmaceuticals

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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