Healthy VolunteersPhase 1NCT05537090
A Study to Assess Effect of BV100 on the Pharmacokinetics of Midazolam in Healthy Participants
A Phase 1 study testing BV100 and Midazolam in people with Healthy Volunteers, run by BioVersys AG at 1 site in Hungary.
Trial summary
To evaluate the effect of repeated doses of intravenous BV100 on the pharma-cokinetics of midazolam and 1-hydroxymidazolam. 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
- What is being tested?
- BV100 and Midazolam
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteHungary
- Study dates
- 1 Sep 2022to 30 Sep 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
- Subjects who were able to understand and follow instructions during the study.
- Subjects who signed informed consent.
- Male subjects ≥18 and ≤55 years of age; female subjects ≥18 and ≤55 years of age of nonchildbearing potential defined as follows:
- Female subjects 50 years of age or older, in menopause for 24 con-secutive months and not receiving any hormone replacement therapy within 24 months prior to inclusion into the study
- Female subjects who underwent surgical sterilization
- Female subjects who underwent hysterectomy
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- Female subjects with documented premature ovarian failure
- Weight within a BMI range of 19.0-30.0 kg/m2.
- Estimated glomerular filtration rate (eGFR) according to the CKD-EPI: ≥90 mL/min (normal renal function)
- Healthy subjects had to be in a good health in the opinion of the study phy-sician, as determined by medical history, ECG, vital signs, physical examina-tion, and clinical laboratory tests.
- Having had no febrile or infectious illness for at least 14 days prior to dos-ing.
- The subject was available to complete the study.
- The subject was complying with the restrictions and requirements of the protocol and, in the opinion of the study physician, was able to complete the study.
Who cannot join
- Unwilling or unable to give informed consent.
- As a result of the medical screening process, the study physician considered the subject unfit for the study.
- Pregnant or lactating women or men with female partners who are lactating or are pregnant.
- Known or suspected history of hypersensitivity to rifabutin or excipients or to drugs of a similar chemical class including rifampicin, rifapentine, rifaximin; history of allergic reactions leading to hospitalisation or any other allergic con-ditions (including drug allergies, asthma, eczema, anaphylactic reactions but excluding untreated, asymptomatic, seasonal allergies) which the Investigator considers may affect the safety of the subject and/or outcome of the study.
- History of antibiotic associated diarrhoea within the last year.
- Volunteers with ECG abnormalities (history, or evidence of second-degree heart block of Mobitz type II, third degree heart block, or any abnormality con-sidered relevant by the Investigator), QTcF > 450 ms, PR > 200 ms, or QRS duration > 110 ms.
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- Supine systolic blood pressure > 140 mmHg or < 90 mmHg or diastolic blood pressure > 90 mmHg or < 50 mmHg at Screening or Day 1 prior to dos-ing (any abnormal blood pressure results may be repeated once and if the re-peat result is within the normal range, it is not considered to have met the ex-clusion criterion). Pulse rate > 90 or < 50 beats per minute at Screening or Day 1 prior to dosing.
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) and creatinine, above the ULN at Screening. Any abnor-mal value of these parameters may be repeated during screening period and if the repeat result is within the laboratory reference range, it is not considered to have met the exclusion criterion.
- Screening values other than AST, ALT, ALP, creatinine, for haematology, biochemistry, or urinalysis must not exceed the reference range. Minor devia-tions from normal are allowed, if they are not clinically significant.
- Leucocytes or neutrophils or lymphocytes below the lower limit of the ref-erence range.
- 11 History of symptomatic, chronic or recurrent infection (e.g. nausea, vomit-ing, diarrhoea, infection with fever) or any viral (including symptomatic herpes zoster), bacterial (including upper respiratory infection), fungal (non-cutaneous) or parasitic infection within 30 days prior to admission to the clini-cal unit.
- 12. A positive pre-study serology test for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies or human immunodeficiency virus (HIV)-1 and/or 2 antibodies.
- 13. Positive Coronavirus (SARS-CoV-2) rapid test and PCR (upon Check-in on Day -1) 14. A positive pre-study drug/alcohol screen. 15. History of epilepsy, other neurological disorders, or neuropsychiatric con-ditions.
- 16. History of seizures. 17. Volunteers who have received any prescribed systemic or topical medica-tion within 4 weeks of the first dose administration.
- 18. Subjects who had used any non-prescribed systemic or topical medication (including herbal remedies) or megadose vitamins (i.e. 20 to 600 times the rec-ommended daily supplement dose) within 7 days prior to dosing, unless in the opinion of the study physician the medication did not interfere with the study procedures or compromise safety.
- 19. 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.
- 20. Regular use of any inducer of metabolism (e.g., barbiturates, rifampin) in the 3 months prior to the first admission to the clinical unit.
- 21. Volunteers who have participated in a clinical study involving administra-tion of an investigational drug (new chemical entity) within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (which-ever is longer).
- 22. 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).
- 23. Excessive consumption of caffeine- or xanthine-containing food or bever-ages (> 5 cups of coffee a day or equivalent) or inability to stop consuming from 48 hours prior to study treatment administration.
- 24. Subjects who smoked more than 10 cigarettes a day. 25. Any use of drugs-of-abuse or alcohol abuse within 2 years prior to the first admission to the clinical unit.
- 26. Inability to understand or communicate reliably with the Investigator or considered by the Investigator to be unable to or unlikely to co-operate with the requirements of the study.
- 27. Any other conditions or factors which in the opinion of the Investigator may interfere with study conduct. Failure to satisfy the Investigator of fitness to participate for any other reason.
- 28. Any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days, or donated plasma within 7 days prior to the first admission to the clinical unit.
- 29. Inability to refrain from using soft contact lenses starting from administra-tion of study treatment until follow-up visit.
- 30. Volunteers who are study site employees or immediate family members of the study site or Sponsor employee.
- 31. Contraindications related to midazolam: Hypersensitivity to the active sub-stance(s) or to any of the excipients, Severe hepatic impairment, Severe res-piratory failure or acute respiratory depression, Myasthenia gravis, Sleep ap-nea, Anatomical respiratory impairment or lung diseases. Note: as per Midazo-lam smpc "Pharmacokinetic interactions with CYP3A4 inhibitors or inducers are more pronounced for oral as compared to oromucosal or parenteral midazo-lam as CYP3A4 enzymes are also present in the upper gastrointestinal tract. Hence, a careful monitoring of the clinical effects and vital signs is recom-mended during the use of midazolam with a CYP3A4 inhibitor even after a single dose".
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Open-label, 3-period Fixed-sequence, Phase I Clinical Study to Evaluate the Effect of BV100 on the Pharmacokinetics of Midazolam and Its Metabolite 1-hydroxymidazolam in Healthy Volunteers
To evaluate the effect of repeated doses of intravenous BV100 on the pharma-cokinetics of midazolam and 1-hydroxymidazolam.
Read the detailed description
A single center, open-label, 3-period fixed-sequence, Phase I clinical Study to Evaluate the Effect of BV100 on the Pharmacokinetics of Midazolam and its metabolite 1-hydroxymidazolam in healthy volunteers
- Conditions
- Healthy Volunteers
- Being tested
- BV100, Midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BV100Drug
Rifabutin for Infusion
MidazolamDrug
Syrup for oral administration
| Study group | Role | What they receive |
|---|---|---|
| BV100 Plus Midazolam | Experimental | A total 2 doses of midazolam and 9 doses of BV100 will be administered to each participant per specified dosing schedule Receives: Drug: BV100; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of repeated doses of intravenous BV100 on the pharmacokinetics of midazolam
Maximum Observed Plasma Concentration (Cmax) of Midazolam
Measured: 0 (predose) up to 24 hours postdose on Day 1 and Day 7
To evaluate the effect of repeated doses of intravenous BV100 on the pharmacokinetics of midazolam
Area Under the Plasma Concentration-Time Curve (AUC) of Midazolam
Measured: 0 (predose) up to 24 hours postdose on Day 1 and Day 7
To evaluate the effect of repeated doses of intravenous BV100 on the pharmacokinetics of 1-hydroxymidazolam
Maximum Observed Plasma Concentration (Cmax) of 1-hydroxymidazolam
Measured: 0 (predose) up to 24 hours postdose on Day 1 and Day 7
To evaluate the effect of repeated doses of intravenous BV100 on the pharmacokinetics of 1-hydroxymidazolam
Area Under the Plasma Concentration-Time Curve (AUC) of 1-hydroxymidazolam
Measured: 0 (predose) up to 24 hours postdose on Day 1 and Day 7
Secondary outcomes (1)
To evaluate the safety, and tolerability in healthy volunteers receiving multiple intravenous doses of BV100 with and without midazolam
Number of Participants with Treatment-Emergent Adverse Events
Measured: 26 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start1 Sep 2022
- Primary completion31 Jul 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Sequential
- Model description
- This is an open-label, 3 period fixed-sequence, Phase 1 clinical study to evalu-ate the effect of multiple doses of BV100 on the Pharmacokinetics on midazo-lam and its metabolite 1-hydroxymidazolam in healthy volunteers.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioVersys AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinical Research Units Hungary
- Responsible party
- Sponsor
- Investigators
- Geza Lakner, Principal investigator, Clinical Research Units Hungary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537090
- Sponsor's protocol ID
- BV100-005
- Status last verified
- Nov 2023
- First submitted
- 7 Sep 2022
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open-label, 3-period Fixed-sequence, Phase I Clinical Study to Evaluate the Effect of BV100 on the Pharmacokinetics of Midazolam and Its Metabolite 1-hydroxymidazolam in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05537090
- Acronym / sponsor ID
- BV100-005
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- BioVersys AGIndustry (pharma, biotech, devices)
- Collaborators
- Clinical Research Units Hungary
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 13 Sep 2022 (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.
To evaluate the effect of repeated doses of intravenous BV100 on the pharma-cokinetics of midazolam and 1-hydroxymidazolam.
Detailed description
A single center, open-label, 3-period fixed-sequence, Phase I clinical Study to Evaluate the Effect of BV100 on the Pharmacokinetics of Midazolam and its metabolite 1-hydroxymidazolam in healthy volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open-label, 3 period fixed-sequence, Phase 1 clinical study to evalu-ate the effect of multiple doses of BV100 on the Pharmacokinetics on midazo-lam and its metabolite 1-hydroxymidazolam in healthy volunteers.
| Arm | Type | Receives |
|---|---|---|
| BV100 Plus Midazolam | Experimental | Drug: BV100, Drug: MidazolamA total 2 doses of midazolam and 9 doses of BV100 will be administered to each participant per specified dosing schedule |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Subjects who were able to understand and follow instructions during the study.
- Subjects who signed informed consent.
- Male subjects ≥18 and ≤55 years of age; female subjects ≥18 and ≤55 years of age of nonchildbearing potential defined as follows:
- Weight within a BMI range of 19.0-30.0 kg/m2.
- Estimated glomerular filtration rate (eGFR) according to the CKD-EPI: ≥90 mL/min (normal renal function)
Key exclusion criteria (27 listed)
- Unwilling or unable to give informed consent.
- As a result of the medical screening process, the study physician considered the subject unfit for the study.
- Pregnant or lactating women or men with female partners who are lactating or are pregnant.
- Known or suspected history of hypersensitivity to rifabutin or excipients or to drugs of a similar chemical class including rifampicin, rifapentine, rifaximin; history of allergic reactions leading to hospitalisation or any other allergic con-ditions (including drug allergies, asthma, eczema, anaphylactic reactions but excluding untreated, asymptomatic, seasonal allergies) which the Investigator considers may affect the safety of the subject and/or outcome of the study.
- History of antibiotic associated diarrhoea within the last year.
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 |
|---|---|---|
| BV100Rifabutin for Infusion | Drug | BV100 Plus Midazolam |
| MidazolamSyrup for oral administration | Drug | BV100 Plus Midazolam |
Primary outcome
To evaluate the effect of repeated doses of intravenous BV100 on the pharmacokinetics of midazolam
Time frame: 0 (predose) up to 24 hours postdose on Day 1 and Day 7
Maximum Observed Plasma Concentration (Cmax) of Midazolam
To evaluate the effect of repeated doses of intravenous BV100 on the pharmacokinetics of midazolam
Time frame: 0 (predose) up to 24 hours postdose on Day 1 and Day 7
Area Under the Plasma Concentration-Time Curve (AUC) of Midazolam
To evaluate the effect of repeated doses of intravenous BV100 on the pharmacokinetics of 1-hydroxymidazolam
Time frame: 0 (predose) up to 24 hours postdose on Day 1 and Day 7
Maximum Observed Plasma Concentration (Cmax) of 1-hydroxymidazolam
To evaluate the effect of repeated doses of intravenous BV100 on the pharmacokinetics of 1-hydroxymidazolam
Time frame: 0 (predose) up to 24 hours postdose on Day 1 and Day 7
Area Under the Plasma Concentration-Time Curve (AUC) of 1-hydroxymidazolam
1 secondary outcome
To evaluate the safety, and tolerability in healthy volunteers receiving multiple intravenous doses of BV100 with and without midazolam
Time frame: 26 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 21 Nov 2023.
- 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.
Geza Lakner principal investigator
Clinical Research Units Hungary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BV100 and Midazolam in people with Healthy Volunteers, run by BioVersys AG at 1 site in Hungary.
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 13 inclusion and 27 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 21 Nov 2023. 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 Hungary. 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?
To evaluate the effect of repeated doses of intravenous BV100 on the pharmacokinetics of midazolam (time frame: 0 (predose) up to 24 hours postdose on Day 1 and Day 7). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2023.