Phase 1 Study Assessing the Safety and Tolerability of CTX-4430

PHASE1CompletedINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

December 31, 2012

Primary Completion Date

July 31, 2013

Study Completion Date

September 30, 2013

Conditions
Pulmonary Inflammation
Interventions
DRUG

CTX-4430

Ascending single oral doses of CTX-4430 will be administered to subjects in 6 cohorts on day 1. Following a 14-day washout, subjects in two of the six cohorts will cross-over, fed a high fat diet and administered different single oral doses of CTX-4430

OTHER

Mannitol

excipient blended with CTX-4430 in capsules

DRUG

Placebo

Single oral doses of placebo will be administered to subjects in 6 cohorts on day 1. Following a 14-day washout, subjects in two of the six cohorts will cross over, fed a high fat diet and administered single oral doses of placebo

DRUG

CTX-4430

Ascending repeat doses of CTX-4430 will be administered orally, once-daily, to subjects in 4 cohorts on days 1-14.

DRUG

Placebo

Repeat doses of placebo will be administered orally, once-daily, to subjects in 4 cohorts on days 1-14.

OTHER

Mannitol

excipient blended with CTX-4430

Trial Locations (1)

6009

Sir Charles Gairdner Hospital, Nedlands

All Listed Sponsors
collaborator

Clinical Network Services

UNKNOWN

collaborator

Linear Clinical Research

INDUSTRY

collaborator

CPR Pharma Services Pty Ltd, Australia

INDUSTRY

lead

Celtaxsys, Inc.

OTHER

NCT01748838 - Phase 1 Study Assessing the Safety and Tolerability of CTX-4430 | Biotech Hunter | Biotech Hunter