Single Dose and Multiple Dose Escalation Trial of an Oral Formulation of MRX-4

PHASE1CompletedINTERVENTIONAL
Enrollment

122

Participants

Timeline

Start Date

August 2, 2016

Primary Completion Date

February 1, 2017

Study Completion Date

February 1, 2017

Conditions
Safety
Interventions
DRUG

Oral single doses of MRX-4

Oral single escalating doses of MRX-4

DRUG

Oral multiple doses of MRX-4

Multiple ascending doses of MRX-4 given twice daily for 10 days

DRUG

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

DRUG

Oral single doses of placebo

Single doses of placebo to match MRX-4

DRUG

Oral multiple doses of placebo

Oral placebo given twice daily for 10 days to match the oral MRX-4

DRUG

Placebo co-administered with omeprazole

Placebo given orally on Day 1 and Day 7, co-administered with omeprazole on Day 3 through Day 7

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Worldwide Clinical Trials

OTHER

lead

MicuRx

INDUSTRY