Drug InteractionPhase 4NCT04006353
The Drug Interaction Between Albuvirtide (ABT) and Rifampin（RIF） in Healthy Adult Subjects
A Phase 4 study testing ABT and RIF in people with Drug Interaction, run by Shanghai Public Health Clinical Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Interaction
- What is being tested?
- ABT and RIF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 11 Jul 2019to 3 Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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；
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 201508
About this study
Official 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
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.
Read the 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
- Being tested
- ABT, RIF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABTDrug
Also called albuvirtide
320 mg, Intravenous infusion
RIFDrug
Also called rifampicin
600mg q.d.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: ABT | Experimental | Intravenous infusion of 320 mg ABT on Day 1, 2, 3, and 8. Receives: 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. Receives: Drug: ABT; Drug: RIF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax) of ABT following ABT 320mg administration with and without RIF 600mg qd
Pharmacokinetic(PK) parameters
Measured: Up to 17 days
Peak Plasma Concentration (Cmax) of RIF 600mg qd administration with and without ABT 320mg
PK parameters
Measured: 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
Measured: 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
Measured: Up to 17 days
Secondary outcomes (3)
Number of subjects with abnormal findings for laboratory parameters
Number of subjects with Grade 3/4 laboratory parameters
Measured: 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.
Measured: 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.
Measured: Up to 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start11 Jul 2019
- Primary completion30 Sep 2019
- Study completion3 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug InteractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Public Health Clinical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hongzhou Lu, Shanghai Public Health Clinical Center
- Investigators
- Hongzhou Lu, Ph.D, Study director, Shanghai Public Health Clinical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04006353
- Sponsor's protocol ID
- FB-ABWT-401
- Status last verified
- Sep 2021
- First submitted
- 27 Jun 2019
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04006353
- Acronym / sponsor ID
- FB-ABWT-401
- Conditions
- Drug Interaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Shanghai Public Health Clinical CenterOther government
- Study start
- 11 Jul 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 3 Dec 2019 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: ABT | Experimental | Drug: ABTIntravenous infusion of 320 mg ABT on Day 1, 2, 3, and 8. |
| Group 2: ABT+RIF | Experimental | Drug: ABT, Drug: RIF600mg Rifampicin once daily from Day 1 to 16. Intravenous infusion of 320 mg ABT on Day 7, 8, 9 and 14. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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；
Key exclusion criteria (13 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABTAlso: albuvirtide320 mg, Intravenous infusion | Drug | Group 1: ABT, Group 2: ABT+RIF |
| RIFAlso: rifampicin600mg q.d. | Drug | Group 2: ABT+RIF |
Primary outcome
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
Peak Plasma Concentration (Cmax) of RIF 600mg qd administration with and without ABT 320mg
Time frame: Up to 17 days
PK parameters
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
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
3 secondary outcomes
Number of subjects with abnormal findings for laboratory parameters
Time frame: Up to 17 days
Number of subjects with adverse events.
Time frame: Up to 17 days
Number of subjects with severity of adverse events
Time frame: Up to 17 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongzhou Lu, Ph.D study director
Shanghai Public Health Clinical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ABT and RIF in people with Drug Interaction, run by Shanghai Public Health Clinical Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plasma Concentration (Cmax) of ABT following ABT 320mg administration with and without RIF 600mg qd (time frame: Up to 17 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2021.