A Study to Assess the Phamacokinetics of BV100 in Participants with Varying Degrees of Hepatic Impairment

NCT05537142 | Completed Phase 1

• 1 other identifier: BV100-008
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the pharmacokinetics (PK) of rifabutin in subjects with hepatic impairment after single intravenous (IV) infusion of BV100

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (2)

• To investigate the pharmacokinetics (PK) of rifabutin in participants with hepatic impairment

  Area under the plasma concentration versus time curve (AUC)

  15 days

• To characterize the single dose pharmacokinetic profile of rifabutin

  Peak Plasma Concentration (Cmax)

  15 days

Secondary Outcomes (3)

• To investigate the safety and tolerability of single intravenous ascending doses of BV100 assessed by the nature, occurrence, and severity of treatment-emergent adverse events

  31 Days

• To determine the plasma concentration of the main metabolite 25-O-Desacetyl-Rifabutin in plasma in participants with hepatic impairment

  15 days

• To determine the plasma concentration of DMI in plasma in subjects with hepatic impairment

  15 days

Study Arms (4)

Group 1

EXPERIMENTAL

Participants with Normal hepatic Function

Drug: BV100

Group 2

EXPERIMENTAL

Participants with mild hepatic impairment: Child-Pugh A (Score 5-6)

Drug: BV100

Group 3

EXPERIMENTAL

Participants with moderate hepatic impairment: Child-Pugh B (Score 7-9)

Drug: BV100

Group 4

EXPERIMENTAL

Participants with severe hepatic impairment: Child-Pugh C (Score 10-15)

Drug: BV100

Interventions

BV100 DRUG

Rifabutin for Infusion

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All participants (Groups 1-4):
• Participants must provide written informed consent prior to any screening procedures being performed.
• Male and non-child bearing potential females between 18 and 75 years of age, inclusive
• Women of non-childbearing potential is defined as women who are physiologically and/or anatomically incapable of becoming pregnant, as now further described:
• They are post-menopausal as evidenced by 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate history of vasomotor symptoms).
• They have had bilateral surgical oophorectomy (with or without hysterectomy), total hysterectomy or bilateral tubal ligation at least six weeks prior. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment she is considered not of childbearing potential.
• Participants must weigh at least 50.0 kg and must have a BMI within the range of 18.0 to 38.0 kg/m2, inclusive, for healthy participants at Screening. For hepatic impairment participants without overt ascites, the BMI should be within the range of 18 to 40 kg/m2. For hepatic impairment participants with overt ascites, the BMI should be within the range of 18 to 45 kg/m2
• Participant is able to read, speak, and understand the local language, to understand and comply with the requirements of the study.
• Must be a non-smoker or agree to smoke no more than 10 cigarettes or equivalent nicotine containing products per day and are committed not to increase the consumption during the study period
• Each participant must match in age (+/- 10 years), gender, weight (+/- 20%), and smoking status to a participant in Groups 2, 3 and/or 4.
• Seated vital signs must be within the following ranges at Screening and Baseline:
• Body temperature, 35.0 to 37.5°C, inclusive
• Systolic blood pressure, 89 to 140 mmHg, inclusive
• Diastolic blood pressure, 50 to 90 mmHg, inclusive
• Pulse rate, 40 to 100 bpm, inclusive

You may not qualify if:

• All participants (Groups 1-4):
• Contraindication or hypersensitivity to the investigational compound/compound class or excipients being used in this study.
• Woman of childbearing potential, or pregnant or lactating females.
• Sexually active males unless they use a condom during intercourse for 8 weeks after BV100 intake and must not father a child in this 8 week period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid. In addition, male participants must not donate sperm for 8 weeks after study drug intake.
• History or presence of clinically significant ECG abnormalities or a family history or presence of prolonged QT-interval syndrome.
• Abnormal ECG findings at Screening:
• Clinically significant ST/T wave abnormalities as determined by the Investigator
• Inability to determine the QT interval on ECG
• Specific to hepatic impaired patients:
• o QTcF \> 480 ms (males and females)
• Specific to healthy control participants:
• PR \> 220 ms, QRS complex \> 120 ms, QTcF \> 450ms for males; QTcF \> 470ms for females.
• Clinically significant cardiac conduction abnormality as determined by the Investigator
• History of clinically significant cardiovascular disease (e.g., congestive heart failure NYHA Class II-IV, atherosclerosis, labile hypertension or uncontrolled hypertension)
• History of psychiatric illness within the past 2 years that may interfere with the ability to comply with the protocol requirements.

Sponsors & Collaborators

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

Study Sites (1)

CRU Hungary Kft., Early Phase Unit

Kistarcsa, H-2143, Hungary

Location

Study Officials

• Geza Lakner, MD

  Clinical Research Units Hungary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: September 13, 2022
• Study Start: September 2, 2022
• Primary Completion: July 30, 2024
• Study Completion: October 30, 2024
• Last Updated: January 14, 2025

Record last verified: 2024-05

Locations

HU (1)