SafetyPhase 1NCT03033342
Single Dose and Multiple Dose Escalation Trial of an Oral Formulation of MRX-4
A Phase 1 study testing Oral single doses of MRX-4, Oral multiple doses of MRX-4 and MRX-4 co-administered with omeprazole in people with Safety, run by MicuRx.
Trial summary
A phase one study of the safety, tolerability, and pharmacokinetics of a new oxazolidinone antibiotic. Cohorts of healthy adults (female and male) will participate in: single dose escalation study of increasing doses of MRX-4 given by mouth others will participate in multiple dose escalation cohorts of MRX-4 given… 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?
- Oral single doses of MRX-4, Oral multiple doses of MRX-4 and MRX-4 co-administered with omeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- No sites listed yet
- Study dates
- 2 Aug 2016to 1 Feb 2017
- 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: Randomized, Double-Blind, Placebo-Controlled Three-Part Phase 1 Study of Safety, Tolerability, Pharmacokinetics, and Food Effect of MRX-4 Administered Orally to Healthy Volunteers in Single and Multiple Ascending Dose Cohorts to Evaluate Drug Interactions With Omeprazole
A phase one study of the safety, tolerability, and pharmacokinetics of a new oxazolidinone antibiotic. Cohorts of healthy adults (female and male) will participate in:
single dose escalation study of increasing doses of MRX-4 given by mouth others will participate in multiple dose escalation cohorts of MRX-4 given twice daily by mouth.
other cohorts of subjects will participate in the study to evaluate the impact of concomitant food or Omeprazole on safety, tolerability and pharmacokinetics of MRX-4
- Conditions
- Safety
- Being tested
- Oral single doses of MRX-4, Oral multiple doses of MRX-4, MRX-4 co-administered with omeprazole, Oral single doses of placebo, Oral multiple doses of placebo
- Keywords
- Phase 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral single doses of MRX-4Drug
Oral single escalating doses of MRX-4
Oral multiple doses of MRX-4Drug
Multiple ascending doses of MRX-4 given twice daily for 10 days
MRX-4 co-administered with omeprazoleDrug
MRX-4 given orally on Day 1 and Day 7, co-administered with omeprazole on Day 3 through Day 7
Oral single doses of placeboDrug
Single doses of placebo to match MRX-4
Oral multiple doses of placeboDrug
Oral placebo given twice daily for 10 days to match the oral MRX-4
Placebo co-administered with omeprazoleDrug
Placebo given orally on Day 1 and Day 7, co-administered with omeprazole on Day 3 through Day 7
| Study group | Role | What they receive |
|---|---|---|
| Oral single doses of MRX-4 | Experimental | Single escalating oral doses of MRX-4 from 250 mg to 3000 mg Receives: Drug: Oral single doses of MRX-4 |
| Oral multiple doses of MRX-4 | Experimental | Twice daily escalating oral doses of MRX-4 for 10 days: 500 mg, 750 mg, 1000 mg, and 1500 mg Receives: Drug: Oral multiple doses of MRX-4 |
| MRX-4 co-administered with omeprazole | Experimental | Impact of concomitant food or omeprazole on the pharmacokinetics of oral MRX-4. Receives: Drug: MRX-4 co-administered with omeprazole |
| Oral single doses of placebo | Placebo comparator | Single oral doses of placebo to match MRX-4 Receives: Drug: Oral single doses of placebo |
| Oral multiple doses of placebo | Placebo comparator | Multiple oral doses of placebo given twice daily for 10 days to match MRX-4 Receives: Drug: Oral multiple doses of placebo |
| Placebo co-administered with omeprazole | Placebo comparator | Oral placebo given on Day 1, Day 7 to match MRX-4 dosing with omeprazole Receives: Drug: Placebo co-administered with omeprazole |
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 of 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 14 (Part III)
Summary of concentration time data for MRX-4 and its metabolites
Concentration time data for MRX-4 and its metabolites in blood and urine
Measured: Pre-dose through 72 hours post dose
Secondary outcomes (3)
Summary of the plasma concentration teim data for MRX-4 under fed or fasted conditions
Concentration time data for MRX-4 and its metabolites in blood and urine under fed and fasted conditions
Measured: Pre-dose through 72 hours post dose
Safety of MRX-4 co-administered with omeprazole
Summary 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 on Day 14
Summary of the plasma concentration time data for MRX-4 co-administered with omeprazole
Concentation time data for MRX-4 and its metabolites in blood and urine with and without omeprazole
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 start2 Aug 2016
- Primary completion1 Feb 2017
- Study completion1 Feb 2017
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 122 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
- NCT03033342
- Sponsor's protocol ID
- MRX4-001
- Status last verified
- Sep 2017
- First submitted
- 19 Dec 2016
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: The study results will be published in the future
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled Three-Part Phase 1 Study of Safety, Tolerability, Pharmacokinetics, and Food Effect of MRX-4 Administered Orally to Healthy Volunteers in Single and Multiple Ascending Dose Cohorts to Evaluate Drug Interactions With Omeprazole
- ClinicalTrials.gov ID
- NCT03033342
- Acronym / sponsor ID
- MRX4-001
- Conditions
- Safety
- Keywords
- Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- MicuRxIndustry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials
- Study start
- 2 Aug 2016 (actual)
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 1 Feb 2017 (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 one study of the safety, tolerability, and pharmacokinetics of a new oxazolidinone antibiotic. Cohorts of healthy adults (female and male) will participate in:
single dose escalation study of increasing doses of MRX-4 given by mouth others will participate in multiple dose escalation cohorts of MRX-4 given twice daily by mouth.
other cohorts of subjects will participate in the study to evaluate the impact of concomitant food or Omeprazole on safety, tolerability and pharmacokinetics of MRX-4
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Oral single doses of MRX-4 | Experimental | Drug: Oral single doses of MRX-4Single escalating oral doses of MRX-4 from 250 mg to 3000 mg |
| Oral multiple doses of MRX-4 | Experimental | Drug: Oral multiple doses of MRX-4Twice daily escalating oral doses of MRX-4 for 10 days: 500 mg, 750 mg, 1000 mg, and 1500 mg |
| MRX-4 co-administered with omeprazole | Experimental | Drug: MRX-4 co-administered with omeprazoleImpact of concomitant food or omeprazole on the pharmacokinetics of oral MRX-4. |
| Oral single doses of placebo | Placebo comparator | Drug: Oral single doses of placeboSingle oral doses of placebo to match MRX-4 |
| Oral multiple doses of placebo | Placebo comparator | Drug: Oral multiple doses of placeboMultiple oral doses of placebo given twice daily for 10 days to match MRX-4 |
| Placebo co-administered with omeprazole | Placebo comparator | Drug: Placebo co-administered with omeprazoleOral placebo given on Day 1, Day 7 to match MRX-4 dosing with omeprazole |
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 |
|---|---|---|
| Oral single doses of MRX-4Oral single escalating doses of MRX-4 | Drug | Oral single doses of MRX-4 |
| Oral multiple doses of MRX-4Multiple ascending doses of MRX-4 given twice daily for 10 days | Drug | Oral multiple doses of MRX-4 |
| MRX-4 co-administered with omeprazoleMRX-4 given orally on Day 1 and Day 7, co-administered with omeprazole on Day 3 through Day 7 | Drug | MRX-4 co-administered with omeprazole |
| Oral single doses of placeboSingle doses of placebo to match MRX-4 | Drug | Oral single doses of placebo |
| Oral multiple doses of placeboOral placebo given twice daily for 10 days to match the oral MRX-4 | Drug | Oral multiple doses of placebo |
| Placebo co-administered with omeprazolePlacebo given orally on Day 1 and Day 7, co-administered with omeprazole on Day 3 through Day 7 | Drug | Placebo co-administered with omeprazole |
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 14 (Part III)
Summary of number of subjects with changes in vital signs, physical examinations, clinical lab data, ECG parameters and adverse events
Summary of concentration time data for MRX-4 and its metabolites
Time frame: Pre-dose through 72 hours post dose
Concentration time data for MRX-4 and its metabolites in blood and urine
3 secondary outcomes
Summary of the plasma concentration teim data for MRX-4 under fed or fasted conditions
Time frame: Pre-dose through 72 hours post dose
Safety of MRX-4 co-administered with omeprazole
Time frame: Screening through end of study on Day 14
Summary of the plasma concentration time data for MRX-4 co-administered with omeprazole
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 9 Nov 2023.
- Individual participant dataSharing planned: No. The study results will be published in the future
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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 Oral single doses of MRX-4, Oral multiple doses of MRX-4 and MRX-4 co-administered with omeprazole 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 9 Nov 2023. 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 14 (Part III)). The study lists 2 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 9 Nov 2023.