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

NCT04006353 | Completed Phase 4

• 1 other identifier: FB-ABWT-401
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Interaction

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Number of subjects with abnormal findings for laboratory parameters

  Up to 17 days

• Number of subjects with adverse events.

  Up to 17 days

• Number of subjects with severity of adverse events

  Up to 17 days

Study Arms (2)

Group 1: ABT

EXPERIMENTAL

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

Drug: ABT

Group 2: ABT+RIF

EXPERIMENTAL

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

Drug: ABT; Drug: RIF

Interventions

ABT DRUG

320 mg, Intravenous infusion

Also known as: albuvirtide

Group 1: ABT; Group 2: ABT+RIF

RIF DRUG

600mg q.d.

Also known as: rifampicin

Group 2: ABT+RIF

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Public Health Clinical Center: lead

Study Sites (1)

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, 201508, China

Location

MeSH Terms

Interventions

albuvirtide; Rifampin

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Hongzhou Lu, Ph.D

  Shanghai Public Health Clinical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 5, 2019
• Study Start: July 11, 2019
• Primary Completion: September 30, 2019
• Study Completion: December 3, 2019
• Last Updated: September 24, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)