HealthyPhase 4PCA 1NCT00729729
Pharmacokinetic Study for PCA Derivate Formulations
A Phase 4 study testing PCA in people with Healthy, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
A comparative bioavailability study of PCA slow release versus immediate release formulations, after a single dose to fasting healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PCA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2008to Dec 2009
- Phase
- Phase 4
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who have completed the informed consent process culminating with written informed consent by the subject.
- Males
- Age 18-45 years
- Abstinence from alcohol for 1 week prior to the study
- Non smoking
- BMI > 19 and < 30
Show all 18Show fewer
- No history or evidence of significant
- cardiovascular,
- hepatic,
- renal,
- hematopoietic,
- gastrointestinal disease,
- endocrine,
- metabolic,
- psychiatric
- psychological disorders
- Normal physical examination
- Within +/- 10% of normal values in laboratory examinations
Who cannot join
- Subjects who suffer from a current medical condition.
- Subjects who smoke.
- Subjects who drink > 20 grams of alcohol per day.
- Subjects who take prescription medication.
- Subjects with an abnormality in screening blood tests
- Known sensitivity to any ingredients in the study drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 4, Three Way Cross-over, Pharmacokinetic Study for PCA Derivate Formulations in Healthy Subjects
A comparative bioavailability study of PCA slow release versus immediate release formulations, after a single dose to fasting healthy subjects.
- Conditions
- Healthy
- Being tested
- PCA
- Keywords
- Comparative, bioavailability, of PCA, formulations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCADrug
Placebo tablet, once
PCADrug
PO, 700mg, once
PCADrug
PO, 1000mg, once
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo Receives: Drug: PCA |
| 2 | Experimental | Slow release PCA derivative Receives: Drug: PCA |
| 3 | Experimental | Slow release PCA derivative higher dose Receives: Drug: PCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCA derivate blood levels
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 posted7 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionFeb 2009
- Study completionDec 2009
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 4
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00729729
- Sponsor's protocol ID
- PCA pharmacokinetics 1
- Acronym
- PCA 1
- Status last verified
- Aug 2008
- First submitted
- 3 Aug 2008
- Last updated
- 28 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4, Three Way Cross-over, Pharmacokinetic Study for PCA Derivate Formulations in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00729729
- Acronym / sponsor ID
- PCA 1 / PCA pharmacokinetics 1
- Conditions
- Healthy
- Keywords
- Comparative, bioavailability, of PCA, formulations
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 7 Aug 2008 (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.
A comparative bioavailability study of PCA slow release versus immediate release formulations, after a single dose to fasting healthy subjects.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: PCAPlacebo |
| 2 | Experimental | Drug: PCASlow release PCA derivative |
| 3 | Experimental | Drug: PCASlow release PCA derivative higher dose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Subjects who have completed the informed consent process culminating with written informed consent by the subject.
- Males
- Age 18-45 years
- Abstinence from alcohol for 1 week prior to the study
- Non smoking
Key exclusion criteria (6 listed)
- Subjects who suffer from a current medical condition.
- Subjects who smoke.
- Subjects who drink > 20 grams of alcohol per day.
- Subjects who take prescription medication.
- Subjects with an abnormality in screening blood tests
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 |
|---|---|---|
| PCAPlacebo tablet, once | Drug | 1 |
| PCAPO, 700mg, once | Drug | 2 |
| PCAPO, 1000mg, once | Drug | 3 |
Primary outcome
PCA derivate blood levels
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 28 Aug 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PCA in people with Healthy, run by Hadassah Medical Organization at 1 site in Israel.
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 18 inclusion and 6 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 28 Aug 2012. 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 Israel. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
PCA derivate blood levels (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 28 Aug 2012.