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

NCT05684718 | Completed Phase 1

• 1 other identifier: BV100-007
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bacterial Infections

Outcome Measures

Primary Outcomes (4)

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

  maximum observed plasma concentration (Cmax) of rifabutin

  Day 1 to Day 21

• 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

  Day 1 to Day 21

• 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

  Day 1 to Day 21

• 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

  Day 1 to Day 21

Secondary Outcomes (1)

• Safety and tolerability of single doses of BV100

  28 Days

Study Arms (1)

BV100 Plus Itraconazole

EXPERIMENTAL

A total 2 doses of BV100 and 14 doses of itraconazole will be administered to each participant per specified dosing schedule

Drug: BV100 (300 mg); Drug: Itraconazole 200 mg

Interventions

BV100 (300 mg) DRUG

Intravenous solution

Also known as: Rifabutin for Infusion

BV100 Plus Itraconazole

Itraconazole 200 mg DRUG

Oral solution

Also known as: Sporanox Oral solution

BV100 Plus Itraconazole

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 who underwent surgical sterilization
• Female subjects who underwent hysterectomy
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• BioVersys AG: lead
• Clinical Research Units Hungary: collaborator

Study Sites (1)

CRU Hungary Kft., Early Phase Unit

Kistarcsa, H-2143, Hungary

Location

MeSH Terms

Conditions

Bacterial Infections

Interventions

Rifabutin; Itraconazole

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Piperazines

Study Officials

• Lisa Husband, MD

  BioVersys SAS

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Fixed sequence

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: January 13, 2023
• Study Start: February 1, 2023
• Primary Completion: September 30, 2023
• Study Completion: October 31, 2023
• Last Updated: November 21, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)