The Drug Interaction Between Albuvirtide (ABT) and Rifampin（RIF） in Healthy Adult Subjects

NCT ID: NCT04006353

Last Updated: 2021-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-11
• Study Completion Date: 2019-12-03

Brief Summary

This study is designed to estimate the drug interaction between RIF and ABT. This will be a single-center, open-label, parallel study in healthy adult subjects.

Detailed Description

The purpose of this study is to describe and compare RIF and ABT pharmacokinetics following administration of 320mg ABT and 600mg RIF.12 subjects will receive 320mg ABT on Days 1、2、3、8 (Treatment 1). And 12 subjects will receive 600mg RIF daily for 16 days from Day 1 to 16, and receive 320mg ABT on Days 7、8、9 and 14 (Treatment 2).

Conditions

Drug Interaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1: ABT

Intravenous infusion of 320 mg ABT on Day 1, 2, 3, and 8.

Group Type: EXPERIMENTAL

ABT

Intervention Type: DRUG

320 mg, Intravenous infusion

Group 2: ABT+RIF

600mg Rifampicin once daily from Day 1 to 16. Intravenous infusion of 320 mg ABT on Day 7, 8, 9 and 14.

Group Type: EXPERIMENTAL

ABT

Intervention Type: DRUG

320 mg, Intravenous infusion

RIF

Intervention Type: DRUG

600mg q.d.

Interventions

ABT

320 mg, Intravenous infusion

Intervention Type: DRUG

RIF

600mg q.d.

Intervention Type: DRUG

Other Intervention Names

albuvirtide; rifampicin

Eligibility Criteria

Inclusion Criteria

• Males and females, age between 18 and 65 years；
• Healthy as determined by a responsible and experienced physician, based on a medical evaluation including physical examination, laboratory tests, Chest X-ray, abdominal B-ultrasound and ECG; No serious liver and kidney dysfunction, normal albumin value, and other indicators are in the normal range；
• Subjects weighing ≥50 kg and their BMI within the range 18.5-27.0 kg/m^2 (inclusive)；
• Agrees not to consume alcohol during the study；
• Both male and female subjects and their partners of childbearing potential agree to use contraception during the study；
• Females of childbearing potential must have a negative serum pregnancy test at Screening visit prior to receiving the first dose of study drug；
• ALT、AST、ALP and TBIL≤1×ULN；
• Willing and able to participate in all aspects of the study, including use of intravenous medication, completion of subjective evaluations, attendance at scheduled clinic visits, and compliance with all protocol requirements as evidenced by providing written informed consent.

Exclusion Criteria

• A positive anti-HIV-1 antibody result；
• A positive pre-study Hepatitis B surface antigen result；
• A Positive Hepatitis C antibody result；
• Syphilis infection as manifest by positive RPR；
• History of tuberculosis (TB) or lung disease；
• Currently active severe chronic diseases, metabolic diseases (such as diabetes), cardiovascular diseases, neurological and psychiatric diseases；
• Any known allergy or antibodies to the study drug or rifampicin；
• Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study；
• Active alcohol or drug abuse；
• Participation in an experimental drug trial(s) within 30 days or 5 half-lives of the Screening Visit；
• Currently active or chronic gastrointestinal dysfunction, or liver and kidney function disorders, would affect the absorption, metabolism, and/or excretion of the study drug. Subjects with a history of cholecystectomy, pepticulcer, inflammatory bowel disease or pancreatitis should be excluded；
• Use other prescription or over-the-counter medications, including vitamins, herbal medicines, or dietary supplements, 7 days prior to dosing or 5 half-life, unless the investigator believes that the drug will not interfere with the study procedure or compromise the safety of the subject；
• Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Public Health Clinical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Hongzhou Lu

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hongzhou Lu, Ph.D

Role: STUDY_DIRECTOR

Shanghai Public Health Clinical Center

Locations

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

FB-ABWT-401

Identifier Type: -

Identifier Source: org_study_id