Healthy VolunteersNCT00162383
Metabolic Capacity of Israeli Populations
A study testing Debrisoquine, Mephenytoin and Dapsone in people with Healthy Volunteers, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The ability to metabolize drugs varies greatly among individuals. Major fraction of this variability lies in genetic polymorphisms of genes encoding for enzymes responsible for both phase I and phase II reactions. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Debrisoquine, Mephenytoin and Dapsone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 1995to Dec 2020
- Phase
- Interventional
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age range 20-50
- Absence of significant disease state
Who cannot join
- The presence of significant disease states
- The regular use of drugs (including birth control pills)
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Organization
Jerusalem
Arik Tzukert, DMD, 00 972 2 6776095, arik@hadassah.org.il
Hadas Lemberg, PhD, 00 972 2 6777572, lhadas@hadassah.org.il
About this study
Official title: Phenotypic and Genotypic Evaluation of Cytochrome P450 Isoforms in Populations of Different Ethnic Composition
The ability to metabolize drugs varies greatly among individuals. Major fraction of this variability lies in genetic polymorphisms of genes encoding for enzymes responsible for both phase I and phase II reactions.
The purpose of this study ws to evaluate the phenotypic activity and the frequency of genetic polymorphisms in different phase II and phase I enzymes among various populations residing in Israel.
- Conditions
- Healthy Volunteers
- Being tested
- Debrisoquine, Mephenytoin, Dapsone, Caffeine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DebrisoquineDrug
MephenytoinDrug
DapsoneDrug
CaffeineDrug
| Study group | Role | What they receive |
|---|---|---|
| Cocktail | Experimental | Not described Receives: Drug: Debrisoquine; Drug: Mephenytoin; Drug: Dapsone; Drug: Caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phenotypic measurements of various P450 and non-P450 enzymes involved in drug metabolism.
Measured: 24 hours
Frequency of genetic polymorphisms in these enzymes among different Israeli populations.
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 posted13 Sep 2005 (estimated)
- Study startJul 1995
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yoseph Caraco, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00162383
- Sponsor's protocol ID
- yc19551-HMO-CTIL
- Status last verified
- Mar 2018
- First submitted
- 11 Sep 2005
- Last updated
- 12 Jun 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotypic and Genotypic Evaluation of Cytochrome P450 Isoforms in Populations of Different Ethnic Composition
- ClinicalTrials.gov ID
- NCT00162383
- Acronym / sponsor ID
- yc19551-HMO-CTIL
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jul 1995
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 13 Sep 2005 (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 ability to metabolize drugs varies greatly among individuals. Major fraction of this variability lies in genetic polymorphisms of genes encoding for enzymes responsible for both phase I and phase II reactions.
The purpose of this study ws to evaluate the phenotypic activity and the frequency of genetic polymorphisms in different phase II and phase I enzymes among various populations residing in Israel.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cocktail | Experimental | Drug: Debrisoquine, Drug: Mephenytoin, Drug: Dapsone, Drug: Caffeine |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age range 20-50
- Absence of significant disease state
Key exclusion criteria (2 listed)
- The presence of significant disease states
- The regular use of drugs (including birth control pills)
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 |
|---|---|---|
| Debrisoquine | Drug | Cocktail |
| Mephenytoin | Drug | Cocktail |
| Dapsone | Drug | Cocktail |
| Caffeine | Drug | Cocktail |
Primary outcome
Phenotypic measurements of various P450 and non-P450 enzymes involved in drug metabolism.
Time frame: 24 hours
Frequency of genetic polymorphisms in these enzymes among different Israeli populations.
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2018.
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Screening Protocol
Pain
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.
Yoseph Caraco, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Debrisoquine, Mephenytoin and Dapsone in people with Healthy Volunteers, 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 2 inclusion and 2 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 12 Jun 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Contact Yoseph Caraco, MD (00 972 2 6778584, caraco@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phenotypic measurements of various P450 and non-P450 enzymes involved in drug metabolism. (time frame: 24 hours). The study lists 2 primary outcomes in all. 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 12 Jun 2018.