Mycobacterium TuberculosisPhase 1NCT00460759
Pharmacokinetic Issues of Moxifloxacin Plus Rifapentine
A Phase 1 study testing Moxifloxacin and Rifapentine in people with Mycobacterium Tuberculosis, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of this study is to determine the pharmacokinetics (how a drug is absorbed, distributed, and eliminated by the body) of moxifloxacin alone versus moxifloxacin given with rifapentine. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mycobacterium Tuberculosis
- What is being tested?
- Moxifloxacin and Rifapentine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to 24 Aug 2008
- Phase
- Phase 1
- 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
- Ability and willingness to provide written informed consent.
- Age greater than or equal to 18 years, and less than or equal to 65 years.
- Within 14 or fewer days prior to enrollment, a complete blood count, comprehensive serum chemistry profile, and HIV antibody test will be performed, with the following laboratory values:
- Serum amino aspartate transferase (AST) at or within the normal limits for the laboratory
- Total bilirubin level at, below, or within the normal limits for the laboratory
- Creatinine level at, below, or within the normal limits for the laboratory
Show all 17Show fewer
- Uric acid at, below, or within the normal limits for the laboratory
- Hemoglobin greater than 12.0 for men, greater than 11.0 for women
- Platelet count greater than or equal to 125,000/cu mm
- Absolute neutrophil count greater than or equal to 1250/cu mm
- Potassium level of at least 3.5 mEq/L
- Serum albumin at or within normal limits for the laboratory
- HIV antibody test negative
- For women of childbearing potential, a negative serum beta-Human Chorionic Gonadatropin (bHCG) pregnancy test, performed at screening and on Day 0.
- During the study and for 14 days after the last dose of study medication, women of childbearing potential must agree to practice a double-barrier method of birth control (e.g., condom plus spermicidal foam, condom plus diaphragm, etc) or to abstain from heterosexual vaginal intercourse since hormonal contraceptives will be prohibited during the study. Female subjects must plan on not getting pregnant during the study and for 14 days after the last dose of study medication.
- Access to a telephone for the duration of the study.
- Within 14 days or fewer prior to enrollment, an electrocardiogram with corrected QT interval (QTc) less than or equal to 0.44 seconds.
Who cannot join
- Breastfeeding
- Known intolerance to either of the study drugs or to fluoroquinolone antibiotics
- Use of rifamycin or fluoroquinolone antibiotics in the 30 days prior to enrollment
- Inability to take oral medications
- History of any renal, hepatic, cardiac (except benign heart murmur), or endocrine disorder; or malignancy; or immunocompromised
- History of any acute or chronic illness that requires current medical therapy
Show all 14Show fewer
- Prior gastrointestinal surgery involving stomach, biliary system, pancreas, or small intestine
- Any medical condition that, in the opinion of the investigator, would interfere with the subject's ability to participate in the protocol
- Any illicit drug use within the preceding 2 months. Subjects must agree to abstain from alcohol, tobacco, and illicit drug use during the study
- Current use of any prescription medication(s)
- Planned use, during the study from Day 0 through the last PK blood draw, of any of the following: prescription medication(s), herbal supplement(s), vitamin(s), mineral supplement(s), or over-the-counter medication(s) with the exception of acetaminophen
- History of prolonged QT syndrome
- Participation in any other investigational drug study within 21 days prior to study entry and during the study
- Inability to participate in pharmacokinetic visits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetic Issues in the Use of Moxifloxacin Plus Rifapentine
The purpose of this study is to determine the pharmacokinetics (how a drug is absorbed, distributed, and eliminated by the body) of moxifloxacin alone versus moxifloxacin given with rifapentine. Researchers believe that understanding how these tuberculosis drugs interact when given together may help to determine the best drug treatment plan for use in future studies. Volunteers will take moxifloxacin daily by mouth for the first part of the study and then moxifloxacin in combination with rifapentine during the second part of the study. Sixteen healthy men and women will be recruited from Johns Hopkins University School of Medicine to volunteer for this study. They will be required to stay in the inpatient unit twice, each time for 84 hours. Study procedures will include having a tube placed in a vein to draw several blood samples over time. Volunteers will participate in the study for a maximum of 48 days, including screening and follow-up visits.
Read the detailed description
New drugs are urgently needed to shorten the duration of tuberculosis (TB) treatment and to facilitate the delivery of directly observed therapy. Preliminary data indicates that a TB treatment regimen that includes moxifloxacin plus rifapentine may have excellent antituberculosis activity that could allow for shortening of total TB treatment duration. However, little is known about possible pharmacokinetic interactions between the two drugs in humans. More specifically, moxifloxacin is metabolized via glucuronide and sulfate conjugation to inactive metabolites. Given that rifapentine induces the activity of phase II enzymes including glucuronosyltransferase and sulphotransferase, it is possible that rifapentine may alter the pharmacokinetics of moxifloxacin. This study will be a prospective, phase I, single center pharmacokinetic study in healthy subjects. The trial will compare the pharmacokinetics of moxifloxacin alone versus moxifloxacin administered with thrice-weekly rifapentine, each administered orally. There will be two parts to the trial: Part I (Days 1-4) during which moxifloxacin is administered alone; and Part II (Days 5-19) during which moxifloxacin is co-administered with thrice-weekly rifapentine. A 24-hour pharmacokinetic profile of moxifloxacin will be obtained following dose administration of moxifloxacin on Day 4 to obtain baseline steady state data at a dose of 400 mg daily. On Day 5, rifapentine will be added to the regimen at a dose of 900 mg thrice weekly, and a 48-hour pharmacokinetic profile for rifapentine and its metabolite, 25-desacetyl-rifapentine will be obtained after the first dose. On Day 19, 72-hour pharmacokinetic profiles for moxifloxacin, rifapentine, and 25-desacetyl-rifapentine will be performed. Safety and tolerability assessments will be performed at designated intervals throughout the study. Beginning on Day 1, subjects will receive moxifloxacin 400 mg daily for 19 days (Days 1-19). Beginning on Day 5, subjects will also receive rifapentine 900 mg thrice weekly (to be administered on Days 5, 7, 9, 12, 14, 16 and 19). Study participants will be 16 healthy adults, ages 18-65, recruited through Johns Hopkins University School of Medicine. The primary study objectives are to: compare, in healthy volunteers, the pharmacokinetics of moxifloxacin alone versus moxifloxacin co-administered with thrice-weekly rifapentine and describe the safety and tolerability of moxifloxacin co-administered with rifapentine. The secondary study objective is to evaluate for rifapentine autoinduction of metabolism in healthy volunteers receiving thrice-weekly rifapentine. The primary safety outcome will be the proportion of subjects with any Grade 3 or 4 toxicity associated with study medications or any serious adverse event. The secondary safety outcomes will be the proportion of subjects with any Grade 1 or 2 toxicity associated with study medications, and the proportion of subjects discontinuing study medications for any reason.
- Conditions
- Mycobacterium Tuberculosis
- Being tested
- Moxifloxacin, Rifapentine
- Keywords
- Mycobacterium tuberculosis, rifapentine, moxifloxacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoxifloxacinDrug
RifapentineDrug
| Study group | Role | What they receive |
|---|---|---|
| Moxifloxacin and Rifapentine | Experimental | Not described Receives: Drug: Moxifloxacin; Drug: Rifapentine |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2007 (estimated)
- Study startJun 2007
- Primary completion24 Aug 2008
- Study completion24 Aug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycobacterium TuberculosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00460759
- Sponsor's protocol ID
- NA_00007322
- Status last verified
- Dec 2017
- First submitted
- 12 Apr 2007
- Last updated
- 7 Dec 2017
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Issues in the Use of Moxifloxacin Plus Rifapentine
- ClinicalTrials.gov ID
- NCT00460759
- Acronym / sponsor ID
- NA_00007322
- Conditions
- Mycobacterium Tuberculosis
- Keywords
- Mycobacterium tuberculosis, rifapentine, moxifloxacin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jun 2007 (actual)
- Primary completion
- 24 Aug 2008 (actual)
- Study completion
- 24 Aug 2008 (actual)
- First posted
- 16 Apr 2007 (estimated)
- 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.
The purpose of this study is to determine the pharmacokinetics (how a drug is absorbed, distributed, and eliminated by the body) of moxifloxacin alone versus moxifloxacin given with rifapentine. Researchers believe that understanding how these tuberculosis drugs interact when given together may help to determine the best drug treatment plan for use in future studies. Volunteers will take moxifloxacin daily by mouth for the first part of the study and then moxifloxacin in combination with rifapentine during the second part of the study. Sixteen healthy men and women will be recruited from Johns Hopkins University School of Medicine to volunteer for this study. They will be required to stay in the inpatient unit twice, each time for 84 hours. Study procedures will include having a tube placed in a vein to draw several blood samples over time. Volunteers will participate in the study for a maximum of 48 days, including screening and follow-up visits.
Detailed description
New drugs are urgently needed to shorten the duration of tuberculosis (TB) treatment and to facilitate the delivery of directly observed therapy. Preliminary data indicates that a TB treatment regimen that includes moxifloxacin plus rifapentine may have excellent antituberculosis activity that could allow for shortening of total TB treatment duration. However, little is known about possible pharmacokinetic interactions between the two drugs in humans. More specifically, moxifloxacin is metabolized via glucuronide and sulfate conjugation to inactive metabolites. Given that rifapentine induces the activity of phase II enzymes including glucuronosyltransferase and sulphotransferase, it is possible that rifapentine may alter the pharmacokinetics of moxifloxacin. This study will be a prospective, phase I, single center pharmacokinetic study in healthy subjects. The trial will compare the pharmacokinetics of moxifloxacin alone versus moxifloxacin administered with thrice-weekly rifapentine, each administered orally. There will be two parts to the trial: Part I (Days 1-4) during which moxifloxacin is administered alone; and Part II (Days 5-19) during which moxifloxacin is co-administered with thrice-weekly rifapentine. A 24-hour pharmacokinetic profile of moxifloxacin will be obtained following dose administration of moxifloxacin on Day 4 to obtain baseline steady state data at a dose of 400 mg daily. On Day 5, rifapentine will be added to the regimen at a dose of 900 mg thrice weekly, and a 48-hour pharmacokinetic profile for rifapentine and its metabolite, 25-desacetyl-rifapentine will be obtained after the first dose. On Day 19, 72-hour pharmacokinetic profiles for moxifloxacin, rifapentine, and 25-desacetyl-rifapentine will be performed. Safety and tolerability assessments will be performed at designated intervals throughout the study. Beginning on Day 1, subjects will receive moxifloxacin 400 mg daily for 19 days (Days 1-19). Beginning on Day 5, subjects will also receive rifapentine 900 mg thrice weekly (to be administered on Days 5, 7, 9, 12, 14, 16 and 19). Study participants will be 16 healthy adults, ages 18-65, recruited through Johns Hopkins University School of Medicine. The primary study objectives are to: compare, in healthy volunteers, the pharmacokinetics of moxifloxacin alone versus moxifloxacin co-administered with thrice-weekly rifapentine and describe the safety and tolerability of moxifloxacin co-administered with rifapentine. The secondary study objective is to evaluate for rifapentine autoinduction of metabolism in healthy volunteers receiving thrice-weekly rifapentine. The primary safety outcome will be the proportion of subjects with any Grade 3 or 4 toxicity associated with study medications or any serious adverse event. The secondary safety outcomes will be the proportion of subjects with any Grade 1 or 2 toxicity associated with study medications, and the proportion of subjects discontinuing study medications for any reason.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moxifloxacin and Rifapentine | Experimental | Drug: Moxifloxacin, Drug: Rifapentine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Ability and willingness to provide written informed consent.
- Age greater than or equal to 18 years, and less than or equal to 65 years.
- Within 14 or fewer days prior to enrollment, a complete blood count, comprehensive serum chemistry profile, and HIV antibody test will be performed, with the following laboratory values:
- Serum amino aspartate transferase (AST) at or within the normal limits for the laboratory
- Total bilirubin level at, below, or within the normal limits for the laboratory
Key exclusion criteria (14 listed)
- Breastfeeding
- Known intolerance to either of the study drugs or to fluoroquinolone antibiotics
- Use of rifamycin or fluoroquinolone antibiotics in the 30 days prior to enrollment
- Inability to take oral medications
- History of any renal, hepatic, cardiac (except benign heart murmur), or endocrine disorder; or malignancy; or immunocompromised
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 |
|---|---|---|
| Moxifloxacin | Drug | Moxifloxacin and Rifapentine |
| Rifapentine | Drug | Moxifloxacin and Rifapentine |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Moxifloxacin and Rifapentine in people with Mycobacterium Tuberculosis, run by Johns Hopkins University at 1 site in United States.
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 17 inclusion and 14 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: stopped early, as of the sponsor's last update on 7 Dec 2017. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early. Results are not available in the source record.
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.
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 7 Dec 2017.