Pharmacokinetics and Tolerability of AV104 (Nalmefene hydrochloride) buccal films in Cholestatic Liver Disease Subjects.

Not Applicable

• Conditions: Health Condition 1: K710- Toxic liver disease with cholestasis

• Registration Number: CTRI/2022/05/042461
• Lead Sponsor: Avior Bio Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 May 2023

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Subjects will be considered eligible for the study based on the following criteria:

1. Subjects willing and able to provide voluntary written informed consent and to follow the protocol requirements

2. Male or female subjects between 18 and 75 years of age (both inclusive) with body weight less than equal to 120 kg and BMI (Body Mass Index) within range of greater than 18.00 and less than 35.00 kg per m2

3. Cholestatic liver disease subjects with known history of persistent generalized pruritus for at least 4 weeks prior to screening

4. 12-lead ECG recording within normal or within acceptable limits or are of no clinical significance with respect to his or her participation in the study as confirmed by the investigator

5. Normal chest X-ray taken within one year before the day of dosing

6. Males, non-fecund females, or females of child-bearing potential, using an approved method of birth control (2 independent highly effective barrier methods of birth control) as per Appendix-A, willing to continue use of the acceptable methods of birth control throughout the study period

7. Female subjects with negative pregnancy test at the time of screening and baseline visit

8. No history of addiction to any recreational drug or drug dependence or alcohol addiction

Exclusion Criteria

Subjects will be excluded from the study based on the following criteria:

1. Known hypersensitivity, allergy or intolerance to nalmefene or other μ-opioid receptor (MOR) antagonist or to any of the excipients of IP

2. History of substance use disorder as per the Diagnostic and Statistical Manual of Mental Disorders â?? 5th edition (DSM-5) criteria within 90 days prior to study entry

3. Subjects with positive urine test for opioid use (UDT)

4. Subjects with positive urine alcohol test

5. Subjects having any clinically significant abnormality of the buccal mucosa which could impact drug absorption

6. Use of an investigational drug within 30 days preceding this study

7. History or presence of hepatic decompensation (e.g. variceal bleeds, poorly controlled ascites, encephalopathy)

8. Subjects with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than five times the ULN

9. Subjects with SCr (Serum creatinine) greater than 2.5 mg per dL

10. Lactating women

11. Any other medical condition or reason that, in the opinion of the investigator or research physician, makes the subject unsuitable to participate in the clinical study

12. Subjects with positive serology for Human Immunodeficiency Virus (HIV) or positive test result for rapid plasma reagin (RPR)

13. Subjects with loss of greater than equal to 350 mL (1 unit) of blood within 90 days of enrolment in the study

14. Subjects with confirmed novel coronavirus infection (COVID-19) or subjects who have taken COVID-19 vaccine within 4 weeks prior to dosing

Study & Design

• Study Type: BA/BE
• Study Design: Not specified