- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01748838
Phase 1 Study Assessing the Safety and Tolerability of CTX-4430
September 9, 2013 updated by: Celtaxsys, Inc.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
96
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Western Australia
-
Nedlands, Western Australia, Australia, 6009
- Sir Charles Gairdner Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part 1: 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
excipient blended with CTX-4430 in capsules
Other Names:
Ascending repeat doses of CTX-4430 will be administered orally, once-daily, to subjects in 4 cohorts on days 1-14.
excipient blended with CTX-4430
Other Names:
|
Placebo Comparator: Part 1: Placebo + Mannitol
|
excipient blended with CTX-4430 in capsules
Other Names:
excipient blended with CTX-4430
Other Names:
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
Repeat doses of placebo will be administered orally, once-daily, to subjects in 4 cohorts on days 1-14.
|
Experimental: Part 2: 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
excipient blended with CTX-4430 in capsules
Other Names:
Ascending repeat doses of CTX-4430 will be administered orally, once-daily, to subjects in 4 cohorts on days 1-14.
excipient blended with CTX-4430
Other Names:
|
Placebo Comparator: Part 2: Placebo + Mannitol
|
excipient blended with CTX-4430 in capsules
Other Names:
excipient blended with CTX-4430
Other Names:
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
Repeat doses of placebo will be administered orally, once-daily, to subjects in 4 cohorts on days 1-14.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
Time Frame: 16 days
|
16 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Janakan Krishnarajah, MB, BS FRACP, Linear Clinical Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
September 1, 2013
Study Registration Dates
First Submitted
December 8, 2012
First Submitted That Met QC Criteria
December 11, 2012
First Posted (Estimate)
December 13, 2012
Study Record Updates
Last Update Posted (Estimate)
September 10, 2013
Last Update Submitted That Met QC Criteria
September 9, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTX-4430-HV-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pulmonary Inflammation
-
Pulmagen TherapeuticsCompletedChronic Obstructive Pulmonary DiseaseUnited Kingdom, Poland
-
Baylor College of MedicineM.D. Anderson Cancer CenterCompleted
-
Xuzhou Medical UniversityUnknownInflammation | Thoracic Surgery | Pulmonary ComplicationChina
-
Fudan UniversityCompletedInflammation | Blood Pressure | Pulmonary Function | CoagulationChina
-
Medical Center AlkmaarUniversity of Amsterdam; Leiden University Medical CenterUnknownInflammation | Chronic Obstructive Pulmonary Disease | Pulmonary EmphysemaNetherlands
-
Hospital Son LlatzerSociedad Española de Neumología y Cirugía Torácica; Hospital Clinic of Barcelona and other collaboratorsCompletedChronic Obstructive Pulmonary DiseaseSpain
-
University of MonastirCompletedChronic Obstructive Pulmonary DiseaseTunisia
-
University of DundeeBoehringer Ingelheim; NHS TaysideCompletedChronic Obstructive Pulmonary DiseaseUnited Kingdom
-
Central Hospital, Nancy, FranceCompletedChronic Obstructive Pulmonary Disease
-
Università degli Studi di FerraraAstraZenecaCompleted
Clinical Trials on CTX-4430
-
Celtaxsys, Inc.Clinical Network Services (CNS) Pty Ltd; Celtaxsys Aus Pty LimitedCompletedAcne VulgarisAustralia, New Zealand
-
Celtaxsys, Inc.CompletedCystic FibrosisUnited States, United Kingdom, Canada, Belgium, France, Germany, Italy
-
Celtaxsys, Inc.CelerionCompletedCystic FibrosisUnited Kingdom
-
Celtaxsys, Inc.Completed
-
Cingulate TherapeuticsRecruitingPhase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301ADHD | Attention Deficit Hyperactivity Disorder | Attention Deficit Disorder With Hyperactivity | ADHD - Combined Type | Attention Deficit Hyperactivity Disorder Combined | Attention Deficit Hyper Activity | Attention-deficit HyperactivityUnited States
-
Chordia Therapeutics, Inc.TheradexRecruitingAcute Myeloid Leukemia | Myelodysplastic SyndromesUnited States
-
Compass TherapeuticsActive, not recruitingMetastatic Colorectal Cancer | Rectal Cancer | Colon CancerUnited States
-
ReNeuron LimitedCompletedPeripheral Arterial DiseaseUnited Kingdom
-
Compass TherapeuticsRecruitingHodgkin Lymphoma | Non Small Cell Lung Cancer | Triple Negative Breast Cancer | Head and Neck Squamous Cell Carcinoma | Malignant MelanomaUnited States
-
Sheba Medical CenterUnknownCerebrotendinous Xanthomatosis (CTX)Israel