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Bacterial InfectionsPhase 1NCT05684718

To Evaluate the Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of BV100

A Phase 1 study testing BV100 (300 mg) and Itraconazole 200 mg in people with Bacterial Infections, run by BioVersys AG at 1 site in Hungary.

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

Phase I clinical study to evaluate the effect of multiple doses of itraconazole on the pharmacokinetics of BV100 in 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
Bacterial Infections
What is being tested?
BV100 (300 mg) and Itraconazole 200 mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteHungary
Study dates
1 Feb 2023to 31 Oct 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 ≤50 years of age of non-childbearing potential defined as follows:
  • Female subjects 50 years of age, in menopause for 24 consecutive 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 have to be in a good health in the opinion of the study physician, as determined by medical history, ECG, vital signs, physical examination, and clinical laboratory tests.
  • Having had no febrile or infectious illness for at least 14 days prior to dosing.
  • The subject was available to complete the study.
  • The subject is willing to comply with the restrictions and requirements of the protocol and, in the opinion of the study physician, will be 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 conditions (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 out-come of the study.
  • History of antibiotic associated diarrhoea within the last year.
  • Subjects 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), QTcF > 450 ms, PR > 210 ms, or QRS duration > 115 ms.
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  • Average supine systolic blood pressure > 140 mmHg or < 90 mmHg or average diastolic blood pressure > 90 mmHg or < 50 mmHg at Screening or Day 1 prior to dosing (any abnormal blood pressure results may be repeated once and if the repeat result is within the normal range, it is not considered to have met the exclusion 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 abnormal 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 deviations from normal are allowed if they are not clinically significant.
  • 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 clinical unit.
  • 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.
  • Positive Coronavirus (SARS-CoV-2) rapid test and/or PCR (upon Check-in on Day -1). If a subject has negative rapid test but a positive PCR, the subject could be included if his/her medical history is consistent with pre-vious COVID-19 infection explaining his/her positive PCR within the last 90 days.
  • A positive pre-study drug/alcohol screen.
  • History of epilepsy, seizures, other neurological disorders, or neuropsychiatric conditions.
  • Subjects who have received any prescribed systemic or topical medication within 4 weeks of the first dose administration.
  • Subjects who had 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 prior to dosing, unless in the opinion of the study physician the medication did not interfere with the study procedures or compromise safety
  • Subjects 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.
  • Regular use of any inducer of metabolism (e.g., barbiturates, rifampin) in the3 months prior to the first dose administration.
  • Subjects who have participated in a clinical study involving administration of an investigational drug (new chemical entity) within the following time period prior to the first dose administration in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
  • Subjects 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).
  • Excessive consumption of caffeine- or xanthine-containing food or beverages (> 5 cups of coffee a day or equivalent) or inability to stop consuming from 48 hours prior to study treatment administration.
  • Subjects who smoked more than 10 cigarettes a day.
  • Any use of drugs-of-abuse or alcohol abuse within 2 years prior to the first admission to the clinical unit.
  • 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.
  • Any other conditions or factors which in the opinion of the Investigator may interfere with study conduct. Failure to satisfy the Investigator of fit-ness to participate for any other reason.
  • 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.
  • Inability to refrain from using soft contact lenses starting from administration of study treatment until follow-up visit.
  • Subjects who are study site employees or immediate family members of the study site or Sponsor employee.
  • Contraindications related to itraconazole: decompensated heart failure, chronic obstructive pulmonary disease, concomitant administration of itraconazole and CYP3A4 metabolized drugs known to prolong the QT interval, may result in potentially fatal ventricular tachyarrhythmias, including torsades de pointe or a life-threatening arrhythmia. Hypersensitivity or previous adverse events associated with azole antifungals.

Trial locations and contacts

1 site in 1 country.

Hungary1 site

  • CRU Hungary Kft., Early Phase Unit

    Kistarcsa, H-2143

Other trials in Hungary

About this study

Official title: A Phase 1 Single Center Open-label, Non-randomized, Fixed Sequence Study in Healthy Volunteers to Assess the Pharmacokinetics (PK) of BV100 When Administered Alone and With Itraconazole

Phase I clinical study to evaluate the effect of multiple doses of itraconazole on the pharmacokinetics of BV100 in healthy volunteers.

Read the detailed description

This is an open-label, fixed-sequence Phase I clinical study to evaluate the effect of multiple doses of itraconazole on the pharmacokinetics of rifabutin, 25 O deacetyl-rifabutin and DMI in healthy volunteers.

Being tested
BV100 (300 mg), Itraconazole 200 mg
Medical subject headings
Bacterial Infections

What participants receive

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

  • BV100 (300 mg)Drug

    Also called Rifabutin for Infusion

    Intravenous solution

  • Itraconazole 200 mgDrug

    Also called Sporanox Oral solution

    Oral solution

Study groups in NCT05684718
Study groupRoleWhat they receive
BV100 Plus ItraconazoleExperimentalA total 2 doses of BV100 and 14 doses of itraconazole will be administered to each participant per specified dosing schedule
Receives: Drug: BV100 (300 mg); Drug: Itraconazole 200 mg

What is being measured

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

  1. To evaluate the effect of repeated doses of itraconazole on the pharmacokinetics of intravenous rifabutin

    maximum observed plasma concentration (Cmax) of rifabutin

    Measured: Day 1 to Day 21

  2. To evaluate the effect of repeated doses of itraconazole on the pharmacokinetics of intravenous rifabutin

    Area Under the Plasma Concentration-Time Curve (AUC) of rifabutin

    Measured: Day 1 to Day 21

  3. To evaluate the effect of repeated doses of itraconazole on the pharmacokinetics of intravenous 25-O-deacetyl-rifabutin

    maximum observed plasma concentration (Cmax) of 25-O-deacetyl-rifabutin

    Measured: Day 1 to Day 21

  4. To evaluate the effect of repeated doses of itraconazole on the pharmacokinetics of intravenous 25-O-deacetyl-rifabutin

    Area Under the Plasma Concentration-Time Curve (AUC) of 25-O-deacetyl-rifabutin

    Measured: Day 1 to Day 21

Secondary outcomes (1)

  1. Safety and tolerability of single doses of BV100

    Number of Participants with Treatment -Emergent Adverse Events

    Measured: 28 Days

Timeline

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

  1. First posted13 Jan 2023
  2. Study start1 Feb 2023
  3. Primary completion30 Sep 2023
  4. Study completion31 Oct 2023

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Fixed sequence
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05684718
Sponsor's protocol ID
BV100-007
Status last verified
Jan 2023
First submitted
5 Jan 2023
Last updated
21 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BV100 (300 mg) and Itraconazole 200 mg in people with Bacterial Infections, 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 29 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 itraconazole on the pharmacokinetics of intravenous rifabutin (time frame: Day 1 to Day 21). 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?

On the ClinicalTrials.gov record for NCT05684718.

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.

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