SafetyPhase 1NCT03033329
Single Dose Escalation and Multiple Dose Escalation Trial of an Intravenous Formulation of MRX-4
A Phase 1 study testing Single intravenous doses of MRX-4, Multiple intravenous doses of MRX-4 and Single dose of intravenous and oral MRX-4 in people with Safety, run by MicuRx.
Trial summary
A Phase 1 study of the safety, tolerability, and pharmacokinetics of a new oxazolidinone antibiotic. In Part 1 cohorts of healthy adults will participate in a single dose escalation study of increasing intravenous doses of MRX-4. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety
- What is being tested?
- Single intravenous doses of MRX-4, Multiple intravenous doses of MRX-4 and Single dose of intravenous and oral MRX-4
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Mar 2018
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects
Who cannot join
- Underlying hepatic, renal, metabolic, hematologic, cardiovascular, or immunologic disorder
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled Three-Part Study of the Safety, Tolerability, and Pharmacokinetics of MRX 4 Administered Intravenously to Healthy Volunteers in Single Ascending and Multiple Ascending Dose Cohorts, and Bioavailability of Oral MRX-4 Versus Intravenous Administration
A Phase 1 study of the safety, tolerability, and pharmacokinetics of a new oxazolidinone antibiotic. In Part 1 cohorts of healthy adults will participate in a single dose escalation study of increasing intravenous doses of MRX-4. In Part 2 cohorts of healthy adults will participate in a multiple dose escalation study of increasing intravenous doses of MRX-4 given twice daily for ten days. Part 3 is a crossover study of oral MRX-4 versus a comparable intravenous dose of MRX-4 to determine bioavailability.
- Conditions
- Safety
- Being tested
- Single intravenous doses of MRX-4, Single intravenous doses of placebo, Multiple intravenous doses of MRX-4, Multiple intravenous doses of placebo, Single dose of intravenous and oral MRX-4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single intravenous doses of MRX-4Drug
Intravenous single escalating doses of MRX-4
Single intravenous doses of placeboDrug
Intravenous single doses of placebo to match MRX-4
Multiple intravenous doses of MRX-4Drug
Multiple ascending doses of MRX-4 given intravenously twice daily for 10 days
Multiple intravenous doses of placeboDrug
Multiple doses of placebo to match MRX-4 given intravenously twice daily for 10 days
Single dose of intravenous and oral MRX-4Drug
Crossover single dose of intravenous and oral MRX-4 given on Day 1 and Day 4
| Study group | Role | What they receive |
|---|---|---|
| Single intravenous doses of MRX-4 | Experimental | Single escalating intravenous doses of MRX-4 from 150 mg to 1800 mg Receives: Drug: Single intravenous doses of MRX-4 |
| Single intravenous doses of placebo | Placebo comparator | Single intravenous doses of placebo to match MRX-4 Receives: Drug: Single intravenous doses of placebo |
| Multiple intravenous doses of MRX-4 | Active comparator | Twice daily escalating intravenous doses of MRX-4 for 10 days: 600 mg, 900 mg, 1200 mg, and 1500 mg Receives: Drug: Multiple intravenous doses of MRX-4 |
| Multiple intravenous doses of placebo | Placebo comparator | Twice daily intravenous doses of placebo to match MRX-4 for 10 days Receives: Drug: Multiple intravenous doses of placebo |
| Single dose of intravenous and oral MRX-4 | Active comparator | Crossover of single dose of intravenous and oral MRX-4 Receives: Drug: Single dose of intravenous and oral MRX-4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of single and multiple ascending doses of MRX-4
Summary statistics of the number of subjects with changes in vital signs, physical examinations, clinical lab data, ecg parameters, and adverse events
Measured: Screening through end of study visit on Day 7 (Part 1), Day 17 (Part II) and Day 15 (Part III)
Secondary outcomes (4)
Plasma concentration time data for MRX-4 and its metabolites
Individual and mean plasma concentration time data for MRX-4 and its metabolites
Measured: Pre-dose through 72 hours post dose
Bioavailability of MRX-I and other MRX-4 metabolites
Levels of MRX-4 and its metabolites in blood
Measured: Pre-dose through 72 hours post dose
Comparison of the pharmacokinetics of oral versus intravenous MRX-4 and its metabolites
Levels of MRX-4 and its metabolites in blood
Measured: Pre-dose through 72 hours post dose
Elimination of MRX-4 and its metabolites in the urine following single dose adminstration
Levels of MRX-4 and its metabolites in urine
Measured: Pre-dose through 72 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study startOct 2016
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SafetyStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- MicuRx
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03033329
- Sponsor's protocol ID
- MRX4-002
- Status last verified
- Jan 2017
- First submitted
- 16 Jan 2017
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled Three-Part Study of the Safety, Tolerability, and Pharmacokinetics of MRX 4 Administered Intravenously to Healthy Volunteers in Single Ascending and Multiple Ascending Dose Cohorts, and Bioavailability of Oral MRX-4 Versus Intravenous Administration
- ClinicalTrials.gov ID
- NCT03033329
- Acronym / sponsor ID
- MRX4-002
- Conditions
- Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- MicuRxIndustry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials
- Study start
- Oct 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 26 Jan 2017 (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.
A Phase 1 study of the safety, tolerability, and pharmacokinetics of a new oxazolidinone antibiotic. In Part 1 cohorts of healthy adults will participate in a single dose escalation study of increasing intravenous doses of MRX-4. In Part 2 cohorts of healthy adults will participate in a multiple dose escalation study of increasing intravenous doses of MRX-4 given twice daily for ten days. Part 3 is a crossover study of oral MRX-4 versus a comparable intravenous dose of MRX-4 to determine bioavailability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Single intravenous doses of MRX-4 | Experimental | Drug: Single intravenous doses of MRX-4Single escalating intravenous doses of MRX-4 from 150 mg to 1800 mg |
| Single intravenous doses of placebo | Placebo comparator | Drug: Single intravenous doses of placeboSingle intravenous doses of placebo to match MRX-4 |
| Multiple intravenous doses of MRX-4 | Active comparator | Drug: Multiple intravenous doses of MRX-4Twice daily escalating intravenous doses of MRX-4 for 10 days: 600 mg, 900 mg, 1200 mg, and 1500 mg |
| Multiple intravenous doses of placebo | Placebo comparator | Drug: Multiple intravenous doses of placeboTwice daily intravenous doses of placebo to match MRX-4 for 10 days |
| Single dose of intravenous and oral MRX-4 | Active comparator | Drug: Single dose of intravenous and oral MRX-4Crossover of single dose of intravenous and oral MRX-4 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy subjects
Key exclusion criteria (1 listed)
- Underlying hepatic, renal, metabolic, hematologic, cardiovascular, or immunologic disorder
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 |
|---|---|---|
| Single intravenous doses of MRX-4Intravenous single escalating doses of MRX-4 | Drug | Single intravenous doses of MRX-4 |
| Single intravenous doses of placeboIntravenous single doses of placebo to match MRX-4 | Drug | Single intravenous doses of placebo |
| Multiple intravenous doses of MRX-4Multiple ascending doses of MRX-4 given intravenously twice daily for 10 days | Drug | Multiple intravenous doses of MRX-4 |
| Multiple intravenous doses of placeboMultiple doses of placebo to match MRX-4 given intravenously twice daily for 10 days | Drug | Multiple intravenous doses of placebo |
| Single dose of intravenous and oral MRX-4Crossover single dose of intravenous and oral MRX-4 given on Day 1 and Day 4 | Drug | Single dose of intravenous and oral MRX-4 |
Primary outcome
Safety of single and multiple ascending doses of MRX-4
Time frame: Screening through end of study visit on Day 7 (Part 1), Day 17 (Part II) and Day 15 (Part III)
Summary statistics of the number of subjects with changes in vital signs, physical examinations, clinical lab data, ecg parameters, and adverse events
4 secondary outcomes
Plasma concentration time data for MRX-4 and its metabolites
Time frame: Pre-dose through 72 hours post dose
Bioavailability of MRX-I and other MRX-4 metabolites
Time frame: Pre-dose through 72 hours post dose
Comparison of the pharmacokinetics of oral versus intravenous MRX-4 and its metabolites
Time frame: Pre-dose through 72 hours post dose
Elimination of MRX-4 and its metabolites in the urine following single dose adminstration
Time frame: Pre-dose through 72 hours post dose
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 22 Mar 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Single intravenous doses of MRX-4, Multiple intravenous doses of MRX-4 and Single dose of intravenous and oral MRX-4 in people with Safety, run by MicuRx.
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 1 inclusion and 1 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 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 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?
Safety of single and multiple ascending doses of MRX-4 (time frame: Screening through end of study visit on Day 7 (Part 1), Day 17 (Part II) and Day 15 (Part III)). 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 22 Mar 2018.