Chronic Kidney InjuryPhase 1NCT02313064

Oral CXA-10 Study in Healthy Volunteers

A Phase 1 study testing CXA-10 in people with Chronic Kidney Injury, run by Complexa, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This will be the first-in-human (FIH) study with the oral formulation of CXA-10. The main purpose of this trial is to demonstrate the safety, tolerability and pharmacokinetics (PK) of CXA-10 and its metabolite(s) administered as single ascending oral doses to healthy volunteers (Part A). Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Chronic Kidney Injury
What is being tested?: CXA-10
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteUnited States
Study dates: Jan 2015to Jun 2015
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 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male subjects and female subjects of non-child bearing potential between the ages of 18 and 50 years (inclusive)
Body mass index (BMI) between 18 and 30 kg/m2 (inclusive) and a weight between 60 kg and 100 kg (inclusive)
In good general health as determined by a thorough medical history and physical examination, ECG, vital signs, and clinical laboratory evaluation. Results of clinical laboratory tests must be without clinically significant abnormalities, including hematology, clinical chemistry and urinalysis. Subjects with blood pressures less than 150/95 mmHg at screening may be enrolled
Subjects must have resting heart rates (HR) greater than or equal to 50 beats per minute at pre-dose
QTcF interval (Fredericia's correction factor) must be less than or equal to 430 msec for males and less than or equal to 450 msec for females at screening and pre-dose. Subjects with any other clinically relevant ECG parameter abnormality (e.g., PR interval, QRS deviation) or any clinically significant ECG abnormality will be excluded from the study. Subjects with a history of congenital long QT syndrome or in the subject's family will be excluded from the study (see Section 6.4)
Adequate venous access to allow for repeated blood sampling

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Ability to comprehend and comply with procedures
Agree to commit to participate in the current protocol
Provide written informed consent prior to any study procedure being performed (all subjects should be able to understand the informed consent form and any other documents that subjects are required to read)

Who cannot join

Female subjects who are pregnant or lactating or who are trying to conceive
Females must not be of child bearing potential (defined as bilateral oophorectomy, hysterectomy, tubal ligation, or post-menopausal (amenorrhea for minimum of 1 year and post-menopausal status confirmed by follicle stimulating hormone (FSH) testing)). Female subjects unable to bear children (e.g. tubal ligation, hysterectomy, or post-menopausal) must have this documented in the case report form (CRF)
Female subjects with a positive urine β-human chorionic gonadotropin (β-hCG) test at screening or positive β-hCG urine at pre-dose
Any clinically relevant abnormality identified on the screening history, physical or laboratory examinations, or any other medical condition or circumstance making the volunteer unsuitable for participation in the study
Any clinical history of cardiovascular events, arrhythmias, fainting, palpitations, personal or family history of congenital prolonged QT syndromes or sudden unexpected death due to a cardiac reason
History of any primary malignancy, including a history of melanoma or suspicious undiagnosed skin lesions, with the exception of basal cell or squamous cell carcinomas of the skin or cervical carcinoma in situ or other malignancies curatively treated and with no evidence of disease for at least 5 years

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History of regular alcohol consumption exceeding 14 units/week for women or 21 units/week for men (one unit equal to 125 mL of wine or 284 mL of beer or a single 25 mL measure of spirits) within 6 months of screening
History of smoking, including e-cigarettes, or use of nicotine-containing products within 1 month of screening
Treatment with any prescription or non-prescription drugs (including vitamins, herbal and dietary supplements) within 7 days or 5 half-lives, whichever is longer, prior to dosing and until collection of the final PK sample. Use of any drug including aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) must be avoided within 7 days prior to the first dose and during this study as it will interfere with the pharmacology of CXA-10. Use of high energy supplements or drinks (especially, those containing caffeine, protein supplements, and weight loss drugs) and smoking cessation products (gum, inhalers, patches, e cigarettes) will be prohibited
-Only acetaminophen will be permitted at doses of 2 grams/day
Sitting blood pressure greater than 150 mmHg systolic and/or greater than 95 mmHg diastolic after 5 minutes rest (feet on floor, arm held at level of heart) at the screening visit
Resting heart rate greater than or equal to 100 beats per minute (BPM) after 5 minutes rest (as above) at the screening visit
Any abnormalities on 12-lead ECG at screening
Any clinically significant murmurs evident on auscultation of the heart (including evidence of mitral valve prolapse)
A positive urine drug screen for drugs of abuse, including alcohol or positive urine cotinine (greater than or equal to 300 ng/mL for cotinine) at the screening visit or at entry to the clinic (Note: urine cotinine required at screening visit only)
Treatment with any investigational drug within 30 days or 5 half-lives (whichever is longer) prior to the beginning of the screening period (this includes investigational formulations of marketed products, inhaled and topical drugs)
Blood collection of greater than 500 mL within 56 days prior to screening
Seropositive for human immunodeficiency virus (HIV) at screening
Positive for Hepatitis B virus surface antigen (HBsAg) or positive Hepatitis C virus antibody (HCV Ab) at screening
Any other condition and/or situation that causes the Investigator to deem a subject unsuitable for the study (e.g., due to expected study medication non-compliance, inability to medically tolerate the study procedures, or a subject's unwillingness to comply with study-related procedures)

Trial locations and contacts

1 site in 1 country.

United States1 site

Jasper Clinical Research & Development, Inc.
Kalamazoo, Michigan, 49007

Other trials in United States

About this study

Official title: A Two-Part, Double-Blind, Third Party Open (Sponsor), Dose-Rising, Placebo-Controlled and Open-Label Exploratory Food Effect Study of the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of CXA-10 in Healthy Volunteers

Read the detailed description

This will be the first-in-human (FIH) study with oral formulation of CXA-10. The main purpose of this trial is to demonstrate the safety, tolerability and pharmacokinetics (PK) of CXA-10 and its metabolite(s) administered as single ascending oral doses to healthy volunteers (Part A). The effects of food on the PK of CXA-10 will also be investigated (Part B). Part A of the study will be a single-center, randomized, double-blind, third party open (sponsor) placebo-controlled study. Sequential single ascending doses will be administered in up to 5 cohorts of subjects. Each cohort of subjects will be randomized to receive a single dose of CXA-10 or placebo in, a fasted state, as illustrated in the table below. Part B of the study will be a single-center, open-label, two-period study conducted in two cohorts of subjects as follows. The selected dose and the interval between Period 1 and Period 2 will be determined based on emerging PK data from Part A. The selected dose will be an intermediate dose level to avoid a food effect interaction that markedly enhances exposure. Subjects who participate in Part B of the study will receive two doses of CXA-10.

Conditions: Chronic Kidney Injury
Being tested: CXA-10, CXA-10 placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CXA-10Drug
Part A has sequential single ascending doses will be administered in up to 5 cohorts of subjects. Each cohort of subjects will be randomized to receive a single dose of CXA-10 or placebo in, a fasted state. Part B has 2 periods and subjects will receive two doses of the selected dose of CXA-10.
CXA-10 placeboDrug

Study groups in NCT02313064
Study group	Role	What they receive
CXA-10	Active comparator	single dose of CXA-10 oral formulation Receives: Drug: CXA-10
CXA-10 placebo	Placebo comparator	single oral doses of CXA-10 placebo Receives: Drug: CXA-10 placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of subjects with Serious and Non-Serious Adverse Events
Safety assessments will be performed prior to, during, and after dosing including a visit on Day 18
Measured: First day of dosing through 30 days after the last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2015Jun 2015

First posted9 Dec 2014 (estimated)
Study startJan 2015
Primary completionMay 2015
Study completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Kidney InjuryStudies 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: Single group
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02313064
Sponsor's protocol ID: CXA-10-201
Status last verified: May 2016
First submitted: 5 Dec 2014
Last updated: 3 May 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Kidney Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Two-Part, Double-Blind, Third Party Open (Sponsor), Dose-Rising, Placebo-Controlled and Open-Label Exploratory Food Effect Study of the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of CXA-10 in Healthy Volunteers
ClinicalTrials.gov ID: NCT02313064
Acronym / sponsor ID: CXA-10-201
Conditions: Chronic Kidney Injury
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Complexa, Inc.Industry (pharma, biotech, devices)
Study start: Jan 2015
Primary completion: May 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 9 Dec 2014 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
CXA-10	Active comparator	Drug: CXA-10single dose of CXA-10 oral formulation
CXA-10 placebo	Placebo comparator	Drug: CXA-10 placebosingle oral doses of CXA-10 placebo

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Male subjects and female subjects of non-child bearing potential between the ages of 18 and 50 years (inclusive)
Body mass index (BMI) between 18 and 30 kg/m2 (inclusive) and a weight between 60 kg and 100 kg (inclusive)
In good general health as determined by a thorough medical history and physical examination, ECG, vital signs, and clinical laboratory evaluation. Results of clinical laboratory tests must be without clinically significant abnormalities, including hematology, clinical chemistry and urinalysis. Subjects with blood pressures less than 150/95 mmHg at screening may be enrolled
Subjects must have resting heart rates (HR) greater than or equal to 50 beats per minute at pre-dose
QTcF interval (Fredericia's correction factor) must be less than or equal to 430 msec for males and less than or equal to 450 msec for females at screening and pre-dose. Subjects with any other clinically relevant ECG parameter abnormality (e.g., PR interval, QRS deviation) or any clinically significant ECG abnormality will be excluded from the study. Subjects with a history of congenital long QT syndrome or in the subject's family will be excluded from the study (see Section 6.4)

Key exclusion criteria (20 listed)

Female subjects who are pregnant or lactating or who are trying to conceive
Females must not be of child bearing potential (defined as bilateral oophorectomy, hysterectomy, tubal ligation, or post-menopausal (amenorrhea for minimum of 1 year and post-menopausal status confirmed by follicle stimulating hormone (FSH) testing)). Female subjects unable to bear children (e.g. tubal ligation, hysterectomy, or post-menopausal) must have this documented in the case report form (CRF)
Female subjects with a positive urine β-human chorionic gonadotropin (β-hCG) test at screening or positive β-hCG urine at pre-dose
Any clinically relevant abnormality identified on the screening history, physical or laboratory examinations, or any other medical condition or circumstance making the volunteer unsuitable for participation in the study
Any clinical history of cardiovascular events, arrhythmias, fainting, palpitations, personal or family history of congenital prolonged QT syndromes or sudden unexpected death due to a cardiac reason

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
CXA-10Part A has sequential single ascending doses will be administered in up to 5 cohorts of subjects. Each cohort of subjects will be randomized to receive a single dose of CXA-10 or placebo in, a fasted state. Part B has 2 periods and subjects will receive two doses of the selected dose of CXA-10.	Drug	CXA-10
CXA-10 placebo	Drug	CXA-10 placebo

Primary outcome

Number of subjects with Serious and Non-Serious Adverse Events
Time frame: First day of dosing through 30 days after the last dose
Safety assessments will be performed prior to, during, and after dosing including a visit on Day 18

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 3 May 2016.
Individual participant dataSharing planned: No

Related trials for Chronic Kidney Injury

Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruiting
Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty
Wound Surgical, Diabetes
Recruiting
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Type 2 Diabetes Mellitus, Acute Kidney Injury
Active, not recruiting
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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.

Thomas Blok, MD principal investigator

Jasper Clinic, Michigan

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 CXA-10 in people with Chronic Kidney Injury, run by Complexa, Inc. at 1 site in United States.

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 9 inclusion and 20 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 3 May 2016. 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 United States. 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?

Number of subjects with Serious and Non-Serious Adverse Events (time frame: First day of dosing through 30 days after the last dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02313064.

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 3 May 2016.