Pulmonary InflammationPhase 1NCT01748838
Phase 1 Study Assessing the Safety and Tolerability of CTX-4430
A Phase 1 study testing CTX-4430 and Mannitol in people with Pulmonary Inflammation, run by Celtaxsys, Inc. at 1 site in Australia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Inflammation
- What is being tested?
- CTX-4430 and Mannitol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteAustralia
- Study dates
- Dec 2012to Sep 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
About this study
Official 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
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
- Being tested
- CTX-4430, Mannitol, Placebo
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTX-4430Drug
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
MannitolOther
Also called osmitrol
excipient blended with CTX-4430 in capsules
PlaceboDrug
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
CTX-4430Drug
Ascending repeat doses of CTX-4430 will be administered orally, once-daily, to subjects in 4 cohorts on days 1-14.
PlaceboDrug
Repeat doses of placebo will be administered orally, once-daily, to subjects in 4 cohorts on days 1-14.
MannitolOther
Also called osmitrol
excipient blended with CTX-4430
| Study group | Role | What they receive |
|---|---|---|
| Part 1: CTX-4430 | Experimental | Not described Receives: Drug: CTX-4430; Other: Mannitol |
| Part 1: Placebo + Mannitol | Placebo comparator | Not described Receives: Other: Mannitol; Drug: Placebo |
| Part 2: CTX-4430 | Experimental | Not described Receives: Drug: CTX-4430; Other: Mannitol |
| Part 2: Placebo + Mannitol | Placebo comparator | Not described Receives: Drug: Placebo; Other: Mannitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionJul 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celtaxsys, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Network Services, Linear Clinical Research, CPR Pharma Services Pty Ltd, Australia
- Responsible party
- Sponsor
- Investigators
- Janakan Krishnarajah, MB, BS FRACP, Principal investigator, Linear Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748838
- Sponsor's protocol ID
- CTX-4430-HV-001
- Status last verified
- Sep 2013
- First submitted
- 8 Dec 2012
- Last updated
- 10 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01748838
- Acronym / sponsor ID
- CTX-4430-HV-001
- Conditions
- Pulmonary Inflammation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Celtaxsys, Inc.University, hospital or other
- Collaborators
- Clinical Network Services, Linear Clinical Research, CPR Pharma Services Pty Ltd, Australia
- Study start
- Dec 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 13 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1: CTX-4430 | Experimental | Drug: CTX-4430, Other: Mannitol |
| Part 1: Placebo + Mannitol | Placebo comparator | Other: Mannitol, Drug: Placebo |
| Part 2: CTX-4430 | Experimental | Drug: CTX-4430, Other: Mannitol |
| Part 2: Placebo + Mannitol | Placebo comparator | Drug: Placebo, Other: Mannitol |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTX-4430Ascending 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 | Drug | Part 1: CTX-4430 |
| MannitolAlso: osmitrolexcipient blended with CTX-4430 in capsules | Other | Part 1: CTX-4430, Part 1: Placebo + Mannitol |
| PlaceboSingle 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 | Part 1: Placebo + Mannitol |
| CTX-4430Ascending repeat doses of CTX-4430 will be administered orally, once-daily, to subjects in 4 cohorts on days 1-14. | Drug | Part 2: CTX-4430 |
| PlaceboRepeat doses of placebo will be administered orally, once-daily, to subjects in 4 cohorts on days 1-14. | Drug | Part 2: Placebo + Mannitol |
| MannitolAlso: osmitrolexcipient blended with CTX-4430 | Other | Part 2: CTX-4430, Part 2: Placebo + Mannitol |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janakan Krishnarajah, MB, BS FRACP principal investigator
Linear Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CTX-4430 and Mannitol in people with Pulmonary Inflammation, run by Celtaxsys, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2013.