Skip to main content
OpenTrials
Completed

NCT Number: NCT04006353

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, 201508, China

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABT

Drug

320 mg, Intravenous infusion

Other names: albuvirtide

RIF

Drug

600mg q.d.

Other names: rifampicin

Primary outcomes

  1. Peak Plasma Concentration (Cmax) of ABT following ABT 320mg administration with and without RIF 600mg qd

    Time frame: Up to 17 days

    Pharmacokinetic(PK) parameters

  2. Peak Plasma Concentration (Cmax) of RIF 600mg qd administration with and without ABT 320mg

    Time frame: Up to 17 days

    PK parameters

  3. Area under the plasma concentration versus time curve (AUC) of ABT following ABT 320mg administration with and without RIF 600mg qd

    Time frame: Up to 17 days

    PK parameters

  4. Area under the plasma concentration versus time curve (AUC) of RIF 600mg qd administration with and without ABT 320mg

    Time frame: Up to 17 days

    PK parameters

Secondary outcomes

  1. Number of subjects with abnormal findings for laboratory parameters

    Time frame: Up to 17 days

    Number of subjects with Grade 3/4 laboratory parameters

  2. Number of subjects with adverse events.

    Time frame: Up to 17 days

    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.

  3. Number of subjects with severity of adverse events

    Time frame: Up to 17 days

    The Division of AIDS table for grading the severity of adult and pediatric adverse events will be used to assess severity.

Sponsors and collaborators

Lead sponsor

Shanghai Public Health Clinical Center

Other Gov

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 5, 2019
Registry last updated
Sep 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.