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

Summary

The purpose of this study is to assess the safety and tolerability of CTX-4430 capsules taken orally once daily in normal healthy volunteers. CTX-4430 is being developed to treat lung inflammation that occurs in cystic fibrosis (CF). This study includes two-parts: Part 1 assesses single dosing; and Part 2 assesses repeat dosing for 14 days. Each part will include several dosages. During the single-dose part of the study, following a 14-day washout period, two cohorts will be assessed for potential effects on tolerability when fed at the time of dosing. For both parts of the study, blood samples will be collected for PK assay validation.

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

Sponsors & Collaborators

• Clinical Network Services

  collaborator UNKNOWN

• Linear Clinical Research

  collaborator INDUSTRY

• CPR Pharma Services Pty Ltd, Australia

  collaborator INDUSTRY

• Celtaxsys, Inc.

  lead OTHER

Principal Investigators

• Janakan Krishnarajah, MB, BS FRACP · Linear Clinical Research

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-12-31

Primary Completion

2013-07-31

Completion

2013-09-30

Countries

• Australia

Study Locations