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Completed

NCT Number: NCT03464058

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

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.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Sciences

Nottingham, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BOS172767 tablets

Drug

Oral tablets

BOS172767 liquid capsules

Drug

Oral capsules

BOS172767 micronized capsules

Drug

Oral capsules

BOS172767 immediate release capsules

Drug

Oral capsules

BOS172767 matching placebo capsules

Drug

Oral capsules

BOS172767 matching placebo tablets

Drug

Oral tablets

rabeprazole

Drug

Oral tablets

Primary outcomes

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

    Time frame: up to 33 weeks

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

    Time frame: up to 33 weeks

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

    Time frame: up to 33 weeks

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

    Time frame: up to 33 weeks

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

    Time frame: up to 33 weeks

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

    Time frame: up to 33 weeks

  7. Parts 1 and 2: Plasma concentration of BOS172722

    Time frame: 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)

  8. Part 2 (Regimen I): Plasma concentration of BOS172722

    Time frame: 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

  9. Part 3: Plasma concentration of BOS172722

    Time frame: 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

  10. Part 3 (Regimen M): Plasma concentration of BOS172722

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Boston Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 13, 2018
Registry last updated
Nov 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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