HealthyPhase 1/2NCT01505907
Pharmacokinetic Study of CXB909 in Healthy Male Subjects
A Phase 1/2 study testing CXB909 in people with Healthy, run by CeNeRx BioPharma Inc..
Trial summary
The primary objective of this dose escalation study is to examine the safety, tolerability, and pharmacokinetic properties of single-doses of CXB909, compared to placebo, in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CXB909
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Dec 2014
- Phase
- Phase 1/2
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male, 18 to 50 years of age.
- Able to read, understand, and provide written/dated informed consent before screening in the study, and must be willing to comply with all study procedures.
- In good general health as ascertained by thorough medical history, physical examination (PE)including measurement of supine and standing vital signs, clinical laboratory studies, and 12-lead electrocardiogram (EKG).
- Body Mass Index (BMI) > 21 and < 30.
- Willing and able to be confined to the clinical research unit as required by the protocol.
Who cannot join
- Presence of a significant acute or chronic medical disorder that might complicate evaluation of the study drug such as:
- Any cardiovascular or cardiac condition.
- Supine SBP≥145 mmHg and/or DBP ≥90 mmHg at Screening.
- Diabetes mellitus.
- Malignancy and/or chemotherapy within two years of screening, other than basal cell carcinoma. Malignancies more than two years prior may not preclude participation; however, must be reviewed on a case-by-case basis by the CeNeRx BioPharma, Inc., medical monitor.
- Known or suspected hypersensitivity to CXB909.
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- Any gastrointestinal disease or digestive disorder, neurological, pulmonary, hepatic, renal, hematologic, endocrine and/or metabolic disease or disorder.
- Current or past psychiatric illness.
- Use of any prescription medications within 14 days of study drug administration.
- Use of any over-the-counter (OTC) medication within seven days of study drug administration (including herbal remedies).
- History of substance abuse, including alcohol abuse as defined by DSM-IV criteria,within the past 12 months.
- Current use of tobacco products or any nicotine-containing products (e.g., gum, patch)for the prior three months.
- Consumption of alcohol or caffeine/xanthine-containing drinks or foods within 72 hours of dosing on Day 1 (including any type of wines, caffeinated or decaffeinated herbal tea, and grapefruit products (e.g., fresh, canned, or frozen), Seville oranges and pomelos).
- Abnormal screening medical/physical examination, unless the abnormality is considered unlikely to be affected by study participation, or confound interpretation of safety data.
- A clinically significant clinical laboratory or EKG abnormality at screening; includes any of the following: aspartate transaminase (AST), alanine transaminase (ALT), or alkaline phosphate (ALP) >2.0 x the upper limit of normal (ULN); total bilirubin >1.5 x the ULN;serum creatinine >1.5 x the ULN; blood urea nitrogen (BUN) >1.5 x the ULN; and thyroid stimulating hormone (TSH) and/or free thyroxine (T4) outside of the normal limits.
- Test positive for: Urine cannabinoids, cocaine, amphetamines, barbiturates, opiates or benzodiazepines, serum alcohol, hepatitis B or C, or nicotine use.
- HIV/AIDS.
- Participation in a clinical investigation within the last 45 days of screening.
- Any other condition which, in the investigator's opinion, may place the subject at greater than normal risk of developing complications.
- Donation of any blood product (one pint or greater) within the previous eight weeks of screening.
- Planning to donate any blood product within eight weeks of end of study.
About this study
Official title: Phase I, Randomized, Double-Blind, Placebo Controlled, Dose Escalation,Single Dose, Safety, Tolerance, and Pharmacokinetic Study of CXB909 in Healthy Male Volunteers
The primary objective of this dose escalation study is to examine the safety, tolerability, and pharmacokinetic properties of single-doses of CXB909, compared to placebo, in healthy male volunteers. This study may evaluate five (5) dose levels of CXB909; however, the number of dose levels, as well as the dosages, may be adjusted after evaluation of in-study analysis of the safety, tolerability, and pharmacokinetic data. This study will attempt to identify the maximum tolerated single dose of CXB909.
- Conditions
- Healthy
- Being tested
- CXB909
- Keywords
- Pharmacokinetics, Safety, Healthy Males
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CXB909Drug
CXB909
| Study group | Role | What they receive |
|---|---|---|
| CXB909 15mg | Experimental | CXB909 15mg Receives: Drug: CXB909 |
| CXB909 30mg | Experimental | Not described Receives: Drug: CXB909 |
| CXB909 60mg | Experimental | Not described Receives: Drug: CXB909 |
| CXB909 120mg | Experimental | Dose Receives: Drug: CXB909 |
| CXB909 250mg | Experimental | Not described Receives: Drug: CXB909 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Parameters
The PK parameters to be determined will include: Tmax, t1/2, Cmax, AUClast, AUCinf, Vd/F and CL/F.
Measured: 1 Week
Secondary outcomes (1)
Safety
Descriptive statistics will be reported for adverse events; systolic and diastolic blood pressures; pulse; the respiration rate; QTC, PR, and QRS intervals; and the laboratory parameters. QTC will be calculated using both the Bazett and Fridericia corrections.
Measured: 1 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 1/2
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CeNeRx BioPharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01505907
- Sponsor's protocol ID
- CXB909-100
- Status last verified
- Jan 2012
- First submitted
- 5 Jan 2012
- Last updated
- 9 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Randomized, Double-Blind, Placebo Controlled, Dose Escalation,Single Dose, Safety, Tolerance, and Pharmacokinetic Study of CXB909 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01505907
- Acronym / sponsor ID
- CXB909-100
- Conditions
- Healthy
- Keywords
- Pharmacokinetics, Safety, Healthy Males
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- CeNeRx BioPharma Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 9 Jan 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 primary objective of this dose escalation study is to examine the safety, tolerability, and pharmacokinetic properties of single-doses of CXB909, compared to placebo, in healthy male volunteers. This study may evaluate five (5) dose levels of CXB909; however, the number of dose levels, as well as the dosages, may be adjusted after evaluation of in-study analysis of the safety, tolerability, and pharmacokinetic data. This study will attempt to identify the maximum tolerated single dose of CXB909.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CXB909 15mg | Experimental | Drug: CXB909CXB909 15mg |
| CXB909 30mg | Experimental | Drug: CXB909 |
| CXB909 60mg | Experimental | Drug: CXB909 |
| CXB909 120mg | Experimental | Drug: CXB909Dose |
| CXB909 250mg | Experimental | Drug: CXB909 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male, 18 to 50 years of age.
- Able to read, understand, and provide written/dated informed consent before screening in the study, and must be willing to comply with all study procedures.
- In good general health as ascertained by thorough medical history, physical examination (PE)including measurement of supine and standing vital signs, clinical laboratory studies, and 12-lead electrocardiogram (EKG).
- Body Mass Index (BMI) > 21 and < 30.
- Willing and able to be confined to the clinical research unit as required by the protocol.
Key exclusion criteria (21 listed)
- Presence of a significant acute or chronic medical disorder that might complicate evaluation of the study drug such as:
- Current or past psychiatric illness.
- Use of any prescription medications within 14 days of study drug administration.
- Use of any over-the-counter (OTC) medication within seven days of study drug administration (including herbal remedies).
- History of substance abuse, including alcohol abuse as defined by DSM-IV criteria,within the past 12 months.
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 |
|---|---|---|
| CXB909CXB909 | Drug | CXB909 120mg, CXB909 15mg, CXB909 250mg, CXB909 30mg, CXB909 60mg |
Primary outcome
Pharmacokinetic Parameters
Time frame: 1 Week
The PK parameters to be determined will include: Tmax, t1/2, Cmax, AUClast, AUCinf, Vd/F and CL/F.
1 secondary outcome
Safety
Time frame: 1 Week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CXB909 in people with Healthy, run by CeNeRx BioPharma Inc..
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 5 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: status not confirmed, as of the sponsor's last update on 9 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Pharmacokinetic Parameters (time frame: 1 Week). 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 9 Jan 2012.