EdemaPhase 1NCT00820092
Xerecept Intravenous Dose Escalation in Japanese and Caucasian Volunteers
A Phase 1 study testing Xerecept 1.0, Xerecept 2.0 and Xerecept 3.0 in people with Edema, run by Celtic Pharma Development Services at 1 site in United States.
Trial summary
1. To investigate the safety and tolerability of Xerecept during and following a 24-hour intravenous administration to healthy Japanese to healthy Japanese and Caucasian subjects 2. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Edema
- What is being tested?
- Xerecept 1.0, Xerecept 2.0 and Xerecept 3.0
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Apr 2009
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female Japanese subjects who are citizens of Japan
- Healthy male and female Caucasian subjects
- Age range 20-45 years
- BMI >19 and <27 kg/m squared
Who cannot join
- Female subjects must not be pregnant at the time of study and use adequate birth control methods before,during and 4 weeks after the study
- Subjects must be negative for HCV and HIV
- Subjects must have negative urine tests for drugs of abuse and alcohol at screening
- Subjects must not have any clinically significant medical conditions
Trial locations and contacts
1 site in 1 country.
United States1 site
West Coast Clinical Trials
Cypress, California, 90630
About this study
Official title: A Phase 1,Dose Escalation Study to Compare the Safety, Tolerability,Pharmacokinetic and Pharmacodynamic Profiles of the 24-hour Intravenous Administration of Xerecept in Healthy Japanese and Caucasian Adult Volunteers
- To investigate the safety and tolerability of Xerecept during and following a 24-hour intravenous administration to healthy Japanese to healthy Japanese and Caucasian subjects
- To compare the PK profile of hCRF during and following a 24-hour intravenous Xerecept administration between healthy Japanese and Caucasian subjects
Read the detailed description
none needed
- Conditions
- Edema
- Being tested
- Xerecept 1.0, Xerecept 2.0, Xerecept 3.0
- Keywords
- Xerecept, Pharmacokinetics, Japanese versus Caucasians
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xerecept 1.0Drug
Also called hCRF infusion, 1.0 ug/kg/hr
24 hour infusion
Xerecept 2.0Drug
Also called hCRF infusion, 2.0 ug/kg/hr
24 hour infusion
Xerecept 3.0Drug
Also called hCRF infusion, 3.0 ug/kg/hr
24 hour infusion
| Study group | Role | What they receive |
|---|---|---|
| Xerecept 1.0 | Active comparator | 1.0 ug/kg/hr hCRF -24 hour IV infusion Receives: Drug: Xerecept 1.0 |
| Xerecept 2.0 | Active comparator | 2.0 ug/kg/hr-24 hour IV infusion Receives: Drug: Xerecept 2.0 |
| Xerecept 3.0 | Active comparator | 3.0 ug/kg/hr-24 hour infusion Receives: Drug: Xerecept 3.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of AEs Clinical laboratory tests( chemistry,hematology,urinalysis) Physical exam and vital signs ECG AUC, Tmax Cmax Terminal half life AUC for cortisol concentration
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionMar 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EdemaStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celtic Pharma Development Services
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00820092
- Sponsor's protocol ID
- Xerecept: CPDS 0805
- Status last verified
- Jul 2013
- First submitted
- 14 Dec 2008
- Last updated
- 30 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1,Dose Escalation Study to Compare the Safety, Tolerability,Pharmacokinetic and Pharmacodynamic Profiles of the 24-hour Intravenous Administration of Xerecept in Healthy Japanese and Caucasian Adult Volunteers
- ClinicalTrials.gov ID
- NCT00820092
- Acronym / sponsor ID
- Xerecept: CPDS 0805
- Conditions
- Edema
- Keywords
- Xerecept, Pharmacokinetics, Japanese versus Caucasians
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Celtic Pharma Development ServicesIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 9 Jan 2009 (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.
- To investigate the safety and tolerability of Xerecept during and following a 24-hour intravenous administration to healthy Japanese to healthy Japanese and Caucasian subjects
- To compare the PK profile of hCRF during and following a 24-hour intravenous Xerecept administration between healthy Japanese and Caucasian subjects
Detailed description
none needed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Xerecept 1.0 | Active comparator | Drug: Xerecept 1.01.0 ug/kg/hr hCRF -24 hour IV infusion |
| Xerecept 2.0 | Active comparator | Drug: Xerecept 2.02.0 ug/kg/hr-24 hour IV infusion |
| Xerecept 3.0 | Active comparator | Drug: Xerecept 3.03.0 ug/kg/hr-24 hour infusion |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male and female Japanese subjects who are citizens of Japan
- Healthy male and female Caucasian subjects
- Age range 20-45 years
- BMI >19 and <27 kg/m squared
Key exclusion criteria (4 listed)
- Female subjects must not be pregnant at the time of study and use adequate birth control methods before,during and 4 weeks after the study
- Subjects must be negative for HCV and HIV
- Subjects must have negative urine tests for drugs of abuse and alcohol at screening
- Subjects must not have any clinically significant medical conditions
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 |
|---|---|---|
| Xerecept 1.0Also: hCRF infusion, 1.0 ug/kg/hr24 hour infusion | Drug | Xerecept 1.0 |
| Xerecept 2.0Also: hCRF infusion, 2.0 ug/kg/hr24 hour infusion | Drug | Xerecept 2.0 |
| Xerecept 3.0Also: hCRF infusion, 3.0 ug/kg/hr24 hour infusion | Drug | Xerecept 3.0 |
Primary outcome
Frequency and severity of AEs Clinical laboratory tests( chemistry,hematology,urinalysis) Physical exam and vital signs ECG AUC, Tmax Cmax Terminal half life AUC for cortisol concentration
Time frame: 24 hours
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 30 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Xerecept 1.0, Xerecept 2.0 and Xerecept 3.0 in people with Edema, run by Celtic Pharma Development Services 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 4 inclusion and 4 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 30 Jul 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 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. 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?
Frequency and severity of AEs Clinical laboratory tests( chemistry,hematology,urinalysis) Physical exam and vital signs ECG AUC, Tmax Cmax Terminal half life AUC for cortisol concentration (time frame: 24 hours). 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 30 Jul 2013.