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Healthy ParticipantsPhase 1NCT04514237

Study to Determine the Relative Bioavailability, Single and Repeat Dose Pharmacokinetics, Safety and Tolerability of BOS172767 Enantiomers in Healthy Subjects

A Phase 1 study testing BOS172767 enantiomer E1 or E2 in people with Healthy Participants, run by Boston Pharmaceuticals at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Part 1 of the study evaluates the safety and tolerability as well as pharmacokinetic properties of a single oral dose of BOS172767 enantiomer E1 and BOS172767 enantiomer E2 following administration to healthy participants. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
BOS172767 enantiomer E1 or E2
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12 participants
Where
1 siteUnited Kingdom
Study dates
12 Sep 2019to 22 Jan 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy males or healthy females of non-childbearing potential
  • Age 18 to 50 years at the time of signing informed consent
  • Body mass index (BMI) of 18.0 to 32.0 kilograms per meters squared (kg/m^2) as measured at screening
  • Must have been willing and able to communicate and participate in the whole study
  • Must have provided written informed consent
  • Must have agreed to adhere to the contraception requirements for this study

Who cannot join

  • Participants who received any investigational medicinal product (IMP) in a clinical research study within the 90 days prior to Day 1
  • Participants who were study site employees, or immediate family members of a study site or sponsor employee
  • Participants who had previously been enrolled and dosed in this study. Participants who had taken part in Part 1 were not permitted to take part in Part 2. Participants who had taken part in study QCL118174/BOS172767-01 (NCT03464058) were allowed to participate in this study.
  • History of any drug or alcohol abuse in the past 2 years
  • Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = 1/2 pint beer, or a 25 milliliter [mL] shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type)
  • A confirmed positive alcohol breath test at screening or admission
Show all 22Show fewer
  • Current smokers and those who had smoked within the last 6 months. A confirmed breath carbon monoxide reading of greater than 20 parts per million (ppm) at screening or admission.
  • Current users of e-cigarettes and nicotine replacement products and those who had used these products within the last 6 months
  • Females of childbearing potential including those who were pregnant or lactating (all female participants must have had a negative serum pregnancy test at screening and had a negative urine pregnancy test at all other time points). A woman was considered of childbearing potential unless she was permanently sterile (hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) or was postmenopausal (had no menses for 12 months without an alternative medical cause and a serum follicle-stimulating hormone [FSH] concentration ≥40 International Units per Liter [IU/L])
  • Participants who did not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening
  • Clinically significant abnormal clinical chemistry, haematology, or urinalysis as judged by the investigator. Participants with Gilbert's Syndrome were not allowed.
  • Participants with alanine aminotransferase (ALT) > 1.5 x upper limit of normal (ULN) at screening (Part 1 and Part 2) or Day -1 (Part 2 only)
  • Confirmed positive drugs of abuse test result
  • Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or human immunodeficiency virus (HIV) results
  • Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of <70 milliliters per minute (mL/min) using the Cockcroft-Gault equation
  • History of clinically significant cardiovascular, renal, hepatic, chronic respiratory, or gastrointestinal disease (including gall stones and/or cholecystectomy), or neurological or psychiatric disorder, as judged by the investigator
  • Serious adverse reaction or serious hypersensitivity to any drug or the IMP excipients
  • Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever was allowed unless it was active.
  • Donation or loss of greater than 400 mL of blood within the previous 3 months
  • Participants who were taking, or had taken, any prescribed or over-the-counter drug (other than 4 grams of paracetamol per day and/or hormone replacement therapy [HRT]) or herbal remedies in the 14 days before IMP administration. Exceptions may have applied on a case by case basis, if considered not to have interfered with the objectives of the study, as determined by the principal investigator.
  • Participants who had any ongoing fungal infections (stable toe nail onchomycosis was allowed)
  • Failure to satisfy the investigator of fitness to participate for any other reason

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Quotient Sciences

    Nottingham

Other trials in United Kingdom

About this study

Official title: A Phase 1 Study to Determine the Relative Bioavailability of BOS172767 Enantiomer E1 and E2 and the Single and Repeat Dose Pharmacokinetics, Safety and Tolerability of BOS172767 Selected Enantiomer in Healthy Subjects

Part 1 of the study evaluates the safety and tolerability as well as pharmacokinetic properties of a single oral dose of BOS172767 enantiomer E1 and BOS172767 enantiomer E2 following administration to healthy participants. Part 2 of the study was to be conducted to assess the safety and tolerability as well as pharmacokinetic properties of one selected enantiomer (BOS172767-Ex) following multiple ascending doses over 14 days of dosing in healthy participants.

Read the detailed description

The study design of Part 1 was a double-blind, placebo-controlled, randomized, single-dose, two-way crossover, followed by two sequential ascending dose periods in 12 healthy participants.

Part 2 was designed to be a double-blind, placebo-controlled, randomized multiple ascending dose (MAD) study in 36 healthy participants (12 per study cohort).

Part 2 was to progress following completion of Part 1, but was not conducted.

Being tested
BOS172767 enantiomer E1 or E2, Placebo
Keywords
BOS172767, enantiomer E1 and E2, relative bioavailability, pharmacokinetics, dose linearity, healthy participants

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BOS172767 enantiomer E1 or E2Drug

    Oral tablets

  • PlaceboDrug

    Oral tablets

Study groups in NCT04514237
Study groupRoleWhat they receive
Part 1: Regimens AB(CD)ExperimentalParticipants received 50 milligrams (mg) BOS172767 E1 tablets or matching placebo (Regimen A) in the fasted state in Period 1, followed by 50 mg BOS172767 E2 tablets or matching placebo (Regimen B) in the fasted state in Period 2. In Period 3 and 4, participants received BOS172767-Ex (selected enantiomer from Part 1 [E1 or E2]) tablets or matching placebo (Regimens C and D, respectively) from Regimen A or B in the fasted state. The Period 3 and 4 dose was selected after review of data from Periods 1 and 2. In each Period, dosing occurred on Day 1, and there was a washout period of at least 10 days or 5 half-lives of the parent (whichever is greater) between each dose of investigational medicinal product.
Receives: Drug: BOS172767 enantiomer E1 or E2; Drug: Placebo
Part 1: Regimens BA(CD)ExperimentalParticipants received 50 milligrams (mg) BOS172767 E2 tablets or matching placebo (Regimen B) in the fasted state in Period 1, followed by 50 mg BOS172767 E1 tablets or matching placebo (Regimen A) in the fasted state in Period 2. In Period 3 and 4, participants received BOS172767-Ex (selected enantiomer from Part 1 [E1 or E2]) tablets or matching placebo (Regimens C and D, respectively) from Regimen A or B in the fasted state. The Period 3 and 4 dose was selected after review of data from Periods 1 and 2. In each Period, dosing occurred on Day 1, and there was a washout period of at least 10 days or 5 half-lives of the parent (whichever is greater) between each dose of investigational medicinal product.
Receives: Drug: BOS172767 enantiomer E1 or E2; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Relative bioavailability of E1 versus E2 (Frel; exposure) of a single oral dose of BOS172767 enantiomer 1 (E1) and enantiomer 2 (E2) following administration to healthy participants based on Cmax, AUC(0-last), and AUC (0-inf)

    Cmax is defined as the maximum observed concentration. AUC(0-last) is defined as the area under the curve from 0 time to the last measurable concentration. AUC (0-inf) is defined as the area under the curve from 0 time extrapolated to infinity.

    Measured: 24 hours post-dose for each of the four 6-day Periods

  2. Part 1: Number of participants with any treatment-emergent adverse event

    Measured: up to Day 6 of each Period; up to a 10-day Follow-up Period after last dose (up to Study Day 59)

  3. Part 1: Number of participants with abnormal, clinically significant physical examination findings

    Measured: up to Day 6 of each Period; up to a 10-day Follow-up Period after last dose (up to Study Day 59)

  4. Part 1: Number of participants with abnormal, clinically significant safety laboratory test findings

    Measured: up to Day 6 of each Period; up to a 10-day Follow-up Period after last dose (up to Study Day 59)

  5. Part 1: Number of participants with abnormal, clinically significant vital sign values

    Measured: up to Day 6 of each Period; up to a 10-day Follow-up Period after last dose (up to Study Day 59)

  6. Part 1: Number of participants with abnormal, clinically significant electrocardiogram findings

    Measured: up to Day 6 of each Period; up to a 10-day Follow-up Period after last dose (up to Study Day 59)

  7. Part 1: Plasma concentration of BOS172767 enantiomers 1 and 2

    Measured: 24 hours post-dose for each of the four 6-day Periods

  8. Part 1: Slope estimates (β) from the power model analysis on Cmax, AUC(0-last), and AUC(0-inf), as a measure of dose proportionality

    Measured: 24 hours post-dose for each of the four 6-day Periods

  9. Part 2: Plasma concentration of BOS172767-Ex (enantiomer E1 or E2)

    Measured: 24 hours post-dose

  10. Part 2: Number of participants with any treatment-emergent adverse event

    Measured: up to Day 24 of Part 2 (up to approximately 18 study weeks)

  11. Part 2: Number of participants with abnormal, clinically significant physical examination findings

    Measured: up to Day 24 of Part 2 (up to approximately 18 study weeks)

  12. Part 2: Number of participants with abnormal, clinically significant safety laboratory test findings

    Measured: up to Day 24 of Part 2 (up to approximately 18 study weeks)

  13. Part 2: Number of participants with abnormal, clinically significant vital sign values

    Measured: up to Day 24 of Part 2 (up to approximately 18 study weeks)

  14. Part 2: Number of participants with abnormal, clinically significant electrocardiogram findings

    Measured: up to Day 24 of Part 2 (up to approximately 18 study weeks)

  15. Part 2: Slope estimates (β) from the power model analysis on Cmax, AUC(0-last), and AUC(0-inf), as a measure of dose proportionality

    Measured: 24 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2020
  2. Study start12 Sep 2019
  3. Primary completion22 Jan 2020
  4. Study completion22 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Sequential
Model description
Part 1 was a two-way crossover design, followed by two sequential ascending dose periods. Part 2 was designed to be a multiple ascending dose design.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04514237
Sponsor's protocol ID
BOS172767-02
Other IDs
2019-002289-11, QSC201870, 2019
Status last verified
Nov 2020
First submitted
12 Aug 2020
Last updated
18 Nov 2020
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BOS172767 enantiomer E1 or E2 in people with Healthy Participants, run by Boston Pharmaceuticals at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Relative bioavailability of E1 versus E2 (Frel; exposure) of a single oral dose of BOS172767 enantiomer 1 (E1) and enantiomer 2 (E2) following administration to healthy participants based on Cmax, AUC(0-last), and AUC (0-inf) (time frame: 24 hours post-dose for each of the four 6-day Periods). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04514237.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2020.

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