Single Dose and Multiple Dose Escalation Trial of an Oral Formulation of MRX-4
NCT ID: NCT03033342
Last Updated: 2023-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
122 participants
INTERVENTIONAL
2016-08-02
2017-02-01
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Oral single doses of MRX-4
Single escalating oral doses of MRX-4 from 250 mg to 3000 mg
Oral single doses of MRX-4
Oral single escalating doses of MRX-4
Oral multiple doses of MRX-4
Twice daily escalating oral doses of MRX-4 for 10 days: 500 mg, 750 mg, 1000 mg, and 1500 mg
Oral multiple doses of MRX-4
Multiple ascending doses of MRX-4 given twice daily for 10 days
MRX-4 co-administered with omeprazole
Impact of concomitant food or omeprazole on the pharmacokinetics of oral MRX-4.
MRX-4 co-administered with omeprazole
MRX-4 given orally on Day 1 and Day 7, co-administered with omeprazole on Day 3 through Day 7
Oral single doses of placebo
Single oral doses of placebo to match MRX-4
Oral single doses of placebo
Single doses of placebo to match MRX-4
Oral multiple doses of placebo
Multiple oral doses of placebo given twice daily for 10 days to match MRX-4
Oral multiple doses of placebo
Oral placebo given twice daily for 10 days to match the oral MRX-4
Placebo co-administered with omeprazole
Oral placebo given on Day 1, Day 7 to match MRX-4 dosing with omeprazole
Placebo co-administered with omeprazole
Placebo given orally on Day 1 and Day 7, co-administered with omeprazole on Day 3 through Day 7
Interventions
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Oral single doses of MRX-4
Oral single escalating doses of MRX-4
Oral multiple doses of MRX-4
Multiple ascending doses of MRX-4 given twice daily for 10 days
MRX-4 co-administered with omeprazole
MRX-4 given orally on Day 1 and Day 7, co-administered with omeprazole on Day 3 through Day 7
Oral single doses of placebo
Single doses of placebo to match MRX-4
Oral multiple doses of placebo
Oral placebo given twice daily for 10 days to match the oral MRX-4
Placebo co-administered with omeprazole
Placebo given orally on Day 1 and Day 7, co-administered with omeprazole on Day 3 through Day 7
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
55 Years
ALL
Yes
Sponsors
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Worldwide Clinical Trials
OTHER
MicuRx
INDUSTRY
Responsible Party
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Other Identifiers
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MRX4-001
Identifier Type: -
Identifier Source: org_study_id
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