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

A Phase 4, Single-center, Open-label, Parallel Study to Evaluate the Drug Interaction Between Albuvirtide (ABT) and Rifampin（RIF） in Healthy Adult Subjects

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.

Study Overview

• Status: Completed
• Conditions: Drug Interaction
• Intervention / Treatment: Drug: ABT; Drug: RIF

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).

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201508
      • Shanghai Public Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: ABT; Intravenous infusion of 320 mg ABT on Day 1, 2, 3, and 8.	Drug: ABT; 320 mg, Intravenous infusion; Other Names: albuvirtide
Experimental: 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.	Drug: ABT; 320 mg, Intravenous infusion; Other Names: albuvirtide; Drug: RIF; 600mg q.d.; Other Names: rifampicin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Plasma Concentration (Cmax) of ABT following ABT 320mg administration with and without RIF 600mg qd	Pharmacokinetic(PK) parameters	Up to 17 days
Peak Plasma Concentration (Cmax) of RIF 600mg qd administration with and without ABT 320mg	PK parameters	Up to 17 days
Area under the plasma concentration versus time curve (AUC) of ABT following ABT 320mg administration with and without RIF 600mg qd	PK parameters	Up to 17 days
Area under the plasma concentration versus time curve (AUC) of RIF 600mg qd administration with and without ABT 320mg	PK parameters	Up to 17 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with abnormal findings for laboratory parameters	Number of subjects with Grade 3/4 laboratory parameters	Up to 17 days
Number of subjects with adverse events.	An adverse event is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.	Up to 17 days
Number of subjects with severity of adverse events	The Division of AIDS table for grading the severity of adult and pediatric adverse events will be used to assess severity.	Up to 17 days

Collaborators and Investigators

• Sponsor: Shanghai Public Health Clinical Center
• Investigators: Study Director: Hongzhou Lu, Ph.D, Shanghai Public Health Clinical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2019
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): December 3, 2019

Study Registration Dates

• First Submitted: June 27, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): September 24, 2021
• Last Update Submitted That Met QC Criteria: September 23, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-Bacterial Agents; Leprostatic Agents; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Antitubercular Agents; Antibiotics, Antitubercular; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 CYP2C8 Inducers; Cytochrome P-450 CYP2C19 Inducers; Cytochrome P-450 CYP2C9 Inducers; Rifampin
• Other Study ID Numbers: FB-ABWT-401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No