Healthy VolunteersPhase 1NCT04654143
Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of BVL-GSK098 in Healthy Volunteers
A Phase 1 study of Healthy Volunteers, run by BioVersys AG at 2 sites in Spain.
Trial summary
This is a phase I single-center, double-blind, randomized, placebo-controlled study to investigate the safety, tolerability and pharmacokinetics and food effect of BVL-GSK098 administered as single and multiple oral doses to healthy volunteers Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesSpain
- Study dates
- 2 Dec 2020to 16 Jan 2023
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteers aged 18 to 55 years inclusive and between 19 and 30 kg/m2 body mass index (BMI) with a minimum weight of 50 kg or men and 45 kg for women, at the time of signing the informed consent.
- Volunteers who are healthy as determined by the investigator based on medical evaluation including medical history, physical examination and cardiac monitoring.
- Volunteers who have a clinically acceptable temperature, blood pressure and pulse rate in supine and standing position (systolic blood pressure between 100-140 mm Hg/ diastolic blood pressure between 50-90 mm Hg / HR between 50-100 bpm). Blood pressure and pulse will be measured after a minimum of 3 minutes of resting.
- Volunteers whose clinical laboratory test results are not clinically relevant and are acceptable to the Investigator.
- Male volunteers must use appropriate contraception (e.g. condoms as part of a double barrier method) from the time of the first dose until 3 months after the post-study visit.
- A female volunteer is eligible to participate if she is of non-childbearing potential, defined as:
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- Is equal to or older than 45 years of age and has not had menses for greater than 1 year,
- Amenorrheic for less than 2 years without a hysterectomy and oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon pretrial (screening) evaluation,
- Whose status is post hysterectomy, oophorectomy or tubal ligation.
- Nonsmokers (i.e., one who has abstained from use of tobaccco and other nicotine-containing products for the last 6 months).
- Willingness to stay in the investigational site for up to 11 days.
- Volunteers are capable of giving signed informed consent which included compliance with the requirements and restrictions listed in the consent form and in this protocol.
Who cannot join
- Women of childbearing potential
- Pregnant or lactating women
- Men with female partners who are lactating or are pregnant
- Glomerular Filtration Rate (GFR) < 90 mL/min/1.73m2 as calculated by the Chronic Kidney Disease Epidemiology Collaboration formula.
- Alanine aminotransferase (ALT), Gamma glutamyl transferase (GGT), Aspartate aminotransferase (AST), alkaline phosphatase or serum bilirubin levels must not exceed the upper limit of normal (ULN)
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
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- A positive test for HIV antibody.
- A positive pre-study drug/alcohol screen.
- Volunteers who consume more than 21 units of alcohol per week or who have a significant history of alcoholism or drug/chemical abuse (one unit of alcohol equals ½ pint [285 mL] of beer or lager, one glass [125 mL] of wine, or 30 mL of 40% of alcohol by volume distilled spirits).
- Volunteers who are study site employees, or immediate family members of a study site or sponsor employee.
- Volunteers with ECG abnormalities (history, or evidence of second-degree heart block of Mobitz type II, third degree heart block, or any abnormality considered relevant by the Investigator), QTcB or QTcF >450 ms or PR>220 ms).
- Volunteers with a history of additional risk factors for torsade de pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator.
- History of seizures.
- Volunteers who have received any prescribed systemic or topical medication within 4 weeks of the first dose administration.
- Volunteers who have used any non-prescribed systemic or topical medication (including herbal remedies) or megadose vitamins (i.e. 20 to 600 times the recommended daily supplement dose) within 7 days of the first dose administration, unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety.
- Volunteers who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of the first dose administration.
- Volunteers who have participated in other clinical trials during the previous 90 days (drug to drug period) in which an investigational drug or a commercially available drug was tested.
- Exposure to more than 4 new chemical entities in the last 12 months before the first dosing day in this study.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56-day period.
- Failure to satisfy the investigator of fitness to participate for any other reason
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
CIM Sant Pau
Barcelona, 08041
Hospital Universitario de La Princesa
Madrid, 28006
About this study
Official title: A Phase I, Double-blind, Randomized, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics and Food Effect of BVL-GSK098 Administered as Single and Multiple Oral Doses to Healthy Volunteers
This is a phase I single-center, double-blind, randomized, placebo-controlled study to investigate the safety, tolerability and pharmacokinetics and food effect of BVL-GSK098 administered as single and multiple oral doses to healthy volunteers
Read the detailed description
This is an exploratory, first-in-human (FIH), double-blind, randomized, placebo-controlled, single and multiple ascending oral dose study in healthy volunteers.The study will be divided into two parts that will be conducted sequentially. Part A is a SAD study to determine the safety, tolerability and PK of single oral doses of BVL-GSK098 in healthy volunteers. In addition, the last cohort of Part A will investigate the effect of food on the PK of BVL-GSK098. Part B is a MAD study to determine the safety, tolerability and PK of BVL-GSK098 following multiple daily oral doses in healthy volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- BVL-GSK098 capsule, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BVL-GSK098 capsule, placeboDrug
Oral QD
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose (SAD) | Experimental | There are multiple dose levels or cohorts. Each cohort has 6 subjects randomized to BVL-GSK098 and 2 subjects randomized to placebo. Receives: Drug: BVL-GSK098 capsule, placebo |
| Multiple Ascending Dose (MAD) | Experimental | There are multiple dose levels or cohorts. Each cohort has 6 subjects randomized to BVL-GSK098 and 2 subjects randomized to placebo. Receives: Drug: BVL-GSK098 capsule, placebo |
| Food Effect | Experimental | This cohort has 6 subjects randomized to BVL-GSK098 and 2 subjects randomized to placebo. Each participant will receive a single oral dose of BVL-GSK098 or placebo administered after the participant eats a high-fat, high calorie breakfast. Receives: Drug: BVL-GSK098 capsule, placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
All AEs will be counted and described within each cohort/dose level, by treatment received and tabulated.
Measured: From screening visit (Day -3 to -30) to end of study (7-10 days post last dose)
Number of participants with clinically significant abnormal findings in hematology parameters
Blood samples will be collected for the assessment of hematology parameters.
Measured: Day 1 until end of study (7-10 days post last dose)
Number of participants with clinically significant abnormal findings in clinical chemistry parameters
Blood samples will be collected for the assessment of chemistry parameters.
Measured: Day 1 until end of study (7-10 days post last dose)
Number of participants with urinalysis findings
Urine samples will be collected for the assessment of urinalysis parameters.
Measured: Day 1 until end of study (7-10 days post last dose)
Number of participants with clinically significant abnormal findings in vital signs
Number of participants with abnormal vital signs will be assessed.
Measured: Day 1 until end of study (7-10 days post last dose)
Number of participants with clinically significant abnormal findings in Electrocardiogram (ECG) Parameters
Triplicate 12-lead ECGs will be obtained
Measured: Day 1 until end of study (7-10 days post last dose)
Secondary outcomes (6)
Maximum observed plasma drug concentration (Cmax) of BVL-GSK098
Blood samples will be collected to evaluate Cmax of BVL-GSK098
Measured: Single dose: up to 72 hours; Multiple dose: up to 10 days
Time to maximum observed plasma drug concentration (tmax) of BVL-GSK098
Blood samples will be collected to evaluate tmax of BVL-GSK098
Measured: Single dose: up to 72 hours; Multiple dose: up to 10 days
Area under the plasma drug concentration versus time curve (AUC) of BVL-GSK098
Blood samples will be collected to evaluate AUC of BVL-GSK098
Measured: Single dose: up to 72 hours; Multiple dose: up to 10 days
Apparent terminal half-life (t1/2) of BVL-GSK098 as appropriate
Blood samples will be collected to evaluate t1/2 of BVL-GSK098
Measured: Single dose: up to 72 hours; Multiple dose: up to 10 days
The effect of food on the plasma concentrations of BVL-GSK098
Blood samples will be collected to evaluate the food effect on plasma concentrations of BVL-GSK098
Measured: up to 72 hours
Observed accumulation ratio following BVL-GSK098 repeat dosing
Measured: up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start2 Dec 2020
- Primary completion30 May 2022
- Study completion16 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioVersys AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rosa M Antonijoan, MD, Principal investigator, Institut de Recerca de l'HSCSP. IIB Sant Pau.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654143
- Sponsor's protocol ID
- BVL-GSK098
- Status last verified
- Jun 2022
- First submitted
- 15 Nov 2020
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pieren M, Abaigar Gutierrez-Solana A, Antonijoan Arbos RM, Boyle GW, Davila M, Davy M, Gitzinger M, Husband L, Martinez-Martinez MS, Mazarro DO, Pefani E, Penman SL, Remuinan MJ, Vlasakakis G, Zeitlinger M, Dale GE. First-in-human study of alpibectir (BVL-GSK098), a novel potent anti-TB drug. J Antimicrob Chemother. 2024 Jun 3;79(6):1353-1361. doi: 10.1093/jac/dkae107.
PubMed 38656557
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Double-blind, Randomized, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics and Food Effect of BVL-GSK098 Administered as Single and Multiple Oral Doses to Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04654143
- Acronym / sponsor ID
- BVL-GSK098
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- BioVersys AGIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 16 Jan 2023 (actual)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase I single-center, double-blind, randomized, placebo-controlled study to investigate the safety, tolerability and pharmacokinetics and food effect of BVL-GSK098 administered as single and multiple oral doses to healthy volunteers
Detailed description
This is an exploratory, first-in-human (FIH), double-blind, randomized, placebo-controlled, single and multiple ascending oral dose study in healthy volunteers.The study will be divided into two parts that will be conducted sequentially. Part A is a SAD study to determine the safety, tolerability and PK of single oral doses of BVL-GSK098 in healthy volunteers. In addition, the last cohort of Part A will investigate the effect of food on the PK of BVL-GSK098. Part B is a MAD study to determine the safety, tolerability and PK of BVL-GSK098 following multiple daily oral doses in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose (SAD) | Experimental | Drug: BVL-GSK098 capsule, placeboThere are multiple dose levels or cohorts. Each cohort has 6 subjects randomized to BVL-GSK098 and 2 subjects randomized to placebo. |
| Multiple Ascending Dose (MAD) | Experimental | Drug: BVL-GSK098 capsule, placeboThere are multiple dose levels or cohorts. Each cohort has 6 subjects randomized to BVL-GSK098 and 2 subjects randomized to placebo. |
| Food Effect | Experimental | Drug: BVL-GSK098 capsule, placeboThis cohort has 6 subjects randomized to BVL-GSK098 and 2 subjects randomized to placebo. Each participant will receive a single oral dose of BVL-GSK098 or placebo administered after the participant eats a high-fat, high calorie breakfast. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Volunteers aged 18 to 55 years inclusive and between 19 and 30 kg/m2 body mass index (BMI) with a minimum weight of 50 kg or men and 45 kg for women, at the time of signing the informed consent.
- Volunteers who are healthy as determined by the investigator based on medical evaluation including medical history, physical examination and cardiac monitoring.
- Volunteers who have a clinically acceptable temperature, blood pressure and pulse rate in supine and standing position (systolic blood pressure between 100-140 mm Hg/ diastolic blood pressure between 50-90 mm Hg / HR between 50-100 bpm). Blood pressure and pulse will be measured after a minimum of 3 minutes of resting.
- Volunteers whose clinical laboratory test results are not clinically relevant and are acceptable to the Investigator.
- Male volunteers must use appropriate contraception (e.g. condoms as part of a double barrier method) from the time of the first dose until 3 months after the post-study visit.
Key exclusion criteria (21 listed)
- Women of childbearing potential
- Pregnant or lactating women
- Men with female partners who are lactating or are pregnant
- Glomerular Filtration Rate (GFR) < 90 mL/min/1.73m2 as calculated by the Chronic Kidney Disease Epidemiology Collaboration formula.
- Alanine aminotransferase (ALT), Gamma glutamyl transferase (GGT), Aspartate aminotransferase (AST), alkaline phosphatase or serum bilirubin levels must not exceed the upper limit of normal (ULN)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BVL-GSK098 capsule, placeboOral QD | Drug | Food Effect, Multiple Ascending Dose (MAD), Single Ascending Dose (SAD) |
Primary outcome
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Time frame: From screening visit (Day -3 to -30) to end of study (7-10 days post last dose)
All AEs will be counted and described within each cohort/dose level, by treatment received and tabulated.
Number of participants with clinically significant abnormal findings in hematology parameters
Time frame: Day 1 until end of study (7-10 days post last dose)
Blood samples will be collected for the assessment of hematology parameters.
Number of participants with clinically significant abnormal findings in clinical chemistry parameters
Time frame: Day 1 until end of study (7-10 days post last dose)
Blood samples will be collected for the assessment of chemistry parameters.
Number of participants with urinalysis findings
Time frame: Day 1 until end of study (7-10 days post last dose)
Urine samples will be collected for the assessment of urinalysis parameters.
Number of participants with clinically significant abnormal findings in vital signs
Time frame: Day 1 until end of study (7-10 days post last dose)
Number of participants with abnormal vital signs will be assessed.
Number of participants with clinically significant abnormal findings in Electrocardiogram (ECG) Parameters
Time frame: Day 1 until end of study (7-10 days post last dose)
Triplicate 12-lead ECGs will be obtained
6 secondary outcomes
Maximum observed plasma drug concentration (Cmax) of BVL-GSK098
Time frame: Single dose: up to 72 hours; Multiple dose: up to 10 days
Time to maximum observed plasma drug concentration (tmax) of BVL-GSK098
Time frame: Single dose: up to 72 hours; Multiple dose: up to 10 days
Area under the plasma drug concentration versus time curve (AUC) of BVL-GSK098
Time frame: Single dose: up to 72 hours; Multiple dose: up to 10 days
Apparent terminal half-life (t1/2) of BVL-GSK098 as appropriate
Time frame: Single dose: up to 72 hours; Multiple dose: up to 10 days
The effect of food on the plasma concentrations of BVL-GSK098
Time frame: up to 72 hours
Observed accumulation ratio following BVL-GSK098 repeat dosing
Time frame: up to 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Derived from this study: PubMed 38656557Pieren M, Abaigar Gutierrez-Solana A, Antonijoan Arbos RM, Boyle GW, Davila M, Davy M, Gitzinger M, Husband L, Martinez-Martinez MS, Mazarro DO, Pefani E, Penman SL, Remuinan MJ, Vlasakakis G, Zeitlinger M, Dale GE. First-in-human study of alpibectir (BVL-GSK098), a novel potent anti-TB drug. J Antimicrob Chemother. 2024 Jun 3;79(6):1353-1361. doi: 10.1093/jac/dkae107.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosa M Antonijoan, MD principal investigator
Institut de Recerca de l'HSCSP. IIB Sant Pau.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Healthy Volunteers, run by BioVersys AG at 2 sites in Spain.
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 12 inclusion and 21 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 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) (time frame: From screening visit (Day -3 to -30) to end of study (7-10 days post last dose)). The study lists 6 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 NCT04654143, which also lists 1 linked publication.
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 Jan 2023; AzTrials last refreshed its copy on 8 Nov 2026.