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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01748838




Registration number
NCT01748838
Ethics application status
Date submitted
8/12/2012
Date registered
13/12/2012
Date last updated
10/09/2013

Titles & IDs
Public title
Phase 1 Study Assessing the Safety and Tolerability of CTX-4430
Scientific title
A Phase I Randomised, Double-Blind, Placebo-Controlled, Ascending Single & Repeat-Dose Study of Safety, Tolerability & Pharmacokinetics of CTX-4430 When Administered Orally to Healthy Adult Subjects
Secondary ID [1] 0 0
CTX-4430-HV-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Inflammation 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CTX-4430
Other interventions - Mannitol
Treatment: Drugs - Placebo
Treatment: Drugs - CTX-4430
Treatment: Drugs - Placebo
Other interventions - Mannitol

Experimental: Part 1: CTX-4430 -

Placebo Comparator: Part 1: Placebo + Mannitol -

Experimental: Part 2: CTX-4430 -

Placebo Comparator: Part 2: Placebo + Mannitol -


Treatment: Drugs: 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 interventions: Mannitol
excipient blended with CTX-4430 in capsules

Treatment: Drugs: 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

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

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

Other interventions: Mannitol
excipient blended with CTX-4430
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability of CTX-4430 in healthy subjects by evaluating changes in physical exams, laboratory tests, vital signs (e.g., blood pressure), pulmonary function tests, ECGs, and the occurrence and severity of adverse events.
Timepoint [1] 0 0
16 days

Eligibility
Key inclusion criteria
- Male and females, 18 to 55 years of age

- Medically healthy

- Body mass index = 18.0 and = 29.9

- Non-tobacco/nicotine-containing product users 6 months prior to the first study drug
administration

- Negative urine drug/alcohol screen prior to Day -1

- Voluntary consent

- Male agrees to be sexually abstinent or to use a condom when engaging in sexual
activity through completion

- Females of childbearing potential must either be sexually inactive for 14 days prior
to the first study drug administration and remain so through 30 days following the
final dosing of the study drug, or have been using one of the following methods of
birth control for the times specified:

- Intra-uterine device in place for at least 3 months prior

- Double barrier method for at least 14 days prior

- Male partner who is surgical sterile at least 6 months prior to first study drug
administration and is sole sexual partner for that female

- Adequate hormonal contraception.Female subjects who become sexually active during the
course of the study must use a double barrier method from the start of sexual activity
through 30 days following the final dosing

- Females of non-childbearing potential have undergone one of the following
sterilization procedures at least 6 months prior to first study drug administration:

- Essure® sterilization and be using a barrier method throughout the study

- bilateral tubal ligation with a barrier method throughout the study

- hysterectomy

- bilateral oophorectomy or be postmenopausal with amenorrhea for at least 1 year prior
to the first study drug administration and follicle stimulating hormone serum levels
=40 mIU/mL

- Subject has a Forced Expiratory Volume of =80% of predicted at screening

- Subject has a resting oxygen saturation >92% on room air
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Positive testing for human immunodeficiency virus,hepatitis B surface antigen, or
hepatitis C antibodies

- Subject is febrile at any stage from screening until pre-dose

- History or presence of alcoholism or drug abuse within 2 years prior to the first
study drug administration

- Hypersensitivity or idiosyncratic reaction to compounds related to CTX-4430.

- Use of any over-the-counter medication,(including herbal products and vitamin
supplements),within the 7 days prior to the Day 1. Use of any nonsteroidal
anti-inflammatory drugs,aspirin,antirheumatic drugs, leukotriene receptor antagonists,
leukotriene enzyme inhibitors within the 14 days prior to the first study drug
administration or 5 half-lives,whichever is longer. Administration or use of
oral,inhaled, intranasal, parenteral, or >1% topical glucocorticoids within the 6
months prior to Day 1

- Use of any significant inhibitors or substrates of OAT3, OCT2 and/or OATP P1/B1 within
30 days prior to the first study drug administration

- Blood donation or significant blood loss within 60 days prior to the first study drug
administration

- Plasma donation within 7 days prior to the first study drug administration.

- Participation in another clinical trial within 30 days prior to the first study drug
administration

- Females who are pregnant or lactating

- Clinically relevant surgery within the past three months prior to first drug
administration

- Personal or family history of prolonged QT syndrome; or a QTc interval >430 msec
(males) or >450 msec (females)

- Sitting blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg

- Pulse is higher than 100 b.p.m.

- Regular alcohol consumption in males >21 units per week and females >14 units per week

- Failure to satisfy the PI of fitness to participate for any reason

- Active infection

- History of seizure

- History or presence of clinically significant cardiovascular, pulmonary, hepatic,
renal, haematological, gastrointestinal, endocrine,immunologic, dermatologic,
neurological, or psychiatric disease

- Use of any prescription medication within 14 days prior to Day 1

- Acute illness within 30 days prior to Day 1

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2013
Sample size
Target
Accrual to date
Final
96
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Other
Name
Celtaxsys, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Clinical Network Services
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Linear Clinical Research
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/Industry
Name [3] 0 0
CPR Pharma Services Pty Ltd, Australia
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01748838
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janakan Krishnarajah, MB, BS FRACP
Address 0 0
Linear Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01748838