PharmacokineticsPhase 1NCT00856752
Evaluation of the Pharmacokinetics of NRL972 Following Pre-Administration of Rifampicin and Cyclosporine
A Phase 1 study testing NRL972 in people with Pharmacokinetics, run by Norgine at 1 site in Bulgaria.
Trial summary
A study in healthy volunteers to determine whether different drugs metabolised by the liver have any effects on how NRL972 is processed within the body. Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- NRL972
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBulgaria
- Study dates
- Jun 2006to Aug 2006
- 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 21 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or females (females of non-childbearing potential or of childbearing potential while taking medically appropriate contraception)
- Caucasian
- Age: 21 - 40 years
- BW 50 - 100 kg
- BMI 20 - 26 kg.m-2
- healthy based on the pre-study examination
- willing and able to provide informed consent
Who cannot join
- General - all subjects
- Previous participation in the trial
- Participant in any other trial during the last 90 days
- Donation of blood during the last 60 days or a history of blood loss exceeding 300 mL within the last 3 months
- History of any clinically relevant allergy (including hypersensitivity to the trial medications)
- Presence of acute or chronic infection
Show all 22Show fewer
- Presence or history of any relevant co-morbidity
- Resting systolic blood pressure > 160 or < 90 mmHg, diastolic blood pressure > 95 or < 50 mmHg
- Clinically relevant ECG-abnormalities, prolonged QTc with > 450 msec in males and > 460 msec in females in particular
- Presence of any relevant abnormality in the laboratory safety tests, especially low haemoglobin, increased liver enzymes
- Positive serology for HBsAg, anti HBc and anti HCV
- Positive HIV test
- Positive alcohol or urine drug test on recruitment (and upon admission)
- History of alcohol and/or drug abuse and/or daily use of > 30 gr alcohol
- Smoking more than 15 cigarettes/day or equivalent of other tobacco products
- Use of prohibited medication
- Suspicion or evidence that the subject is not trustworthy and reliable
- Suspicion or evidence that the subject is not able to make a free consent or to understand the information in this regard
- General - all females
- Positive pregnancy test
- Lactating
- Not using appropriate contraception in pre-menopausal women (note: under the conditions of the present study, women using hormonal contraceptives will be informed that this method is not sufficient during the study and that further i.e. mechanical methods [condom, diaphragm with spermacide gel] should be used in addition).
Trial locations and contacts
1 site in 1 country.
Bulgaria1 site
Dept. Clinical Pharmacology & Therapeutics, MHAPT "Zaritza Johanna" University Hospital
Sofia, 1527
About this study
Official title: A Single-Centre, Open, Controlled, Randomised Cross-Over Study in Healthy Male and Female Volunteers to Evaluate the Pharmacokinetics of Cholyl-Lysyl-Fluorescein (NRL972) in the Presence of Medication-Induced Changes in Cytochrome P450 or Biliary Transporter Proteins. Part A: Interaction With Rifampicin and Cyclosporine
A study in healthy volunteers to determine whether different drugs metabolised by the liver have any effects on how NRL972 is processed within the body.
- Conditions
- Pharmacokinetics
- Being tested
- NRL972
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NRL972Drug
Single intravenous administration of 2 mg NRL972 after pre-treatment with 600 mg p.o. rifampicin once daily from the evening of Day D-7 until the evening of Day D-1
NRL972Drug
Reference test: Single intravenous administration of 2 mg NRL972
NRL972Drug
Single intravenous administration of 2 mg NRL972 injection after pre-treatment with 100 mg cyclosporine on the evening of Day D-1 and on the morning of Day D01 one hour before administration of NRL972
| Study group | Role | What they receive |
|---|---|---|
| T1 | Experimental | Pre-treatment with rifampicin Receives: Drug: NRL972 |
| T2 | Experimental | Pre-treatment with cyclosporin Receives: Drug: NRL972 |
| Reference | Experimental | Administration of NRL001 alone: no pre-treatment Receives: Drug: NRL972 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total clearance by non-compartmental analysis. Apparent terminal disposition half-life t½ by non-compartmental analysis
Measured: Up to 6 hours post dose
Secondary outcomes (1)
Non-compartmental PK-analysis based on the extensive profile (up to last quantifiable data point), the 'short' profile (over the first hour after injection), and the two-point profile based on selected data-pairs over the 1st hour after dosing
Measured: Up to 6 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2009 (estimated)
- Study startJun 2006
- Primary completionJul 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norgine
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hans J Gruss, MD, Study director, Norgine LtdEmil Gatchev, PD Dr, Principal investigator, MHAPT "Zaritza Johanna" University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00856752
- Sponsor's protocol ID
- NRL972-04A/2005 (IN-A)
- Status last verified
- Mar 2009
- First submitted
- 5 Mar 2009
- Last updated
- 6 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Centre, Open, Controlled, Randomised Cross-Over Study in Healthy Male and Female Volunteers to Evaluate the Pharmacokinetics of Cholyl-Lysyl-Fluorescein (NRL972) in the Presence of Medication-Induced Changes in Cytochrome P450 or Biliary Transporter Proteins. Part A: Interaction With Rifampicin and Cyclosporine
- ClinicalTrials.gov ID
- NCT00856752
- Acronym / sponsor ID
- NRL972-04A/2005 (IN-A)
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- NorgineIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Jul 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 6 Mar 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.
A study in healthy volunteers to determine whether different drugs metabolised by the liver have any effects on how NRL972 is processed within the body.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| T1 | Experimental | Drug: NRL972Pre-treatment with rifampicin |
| T2 | Experimental | Drug: NRL972Pre-treatment with cyclosporin |
| Reference | Experimental | Drug: NRL972Administration of NRL001 alone: no pre-treatment |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Males or females (females of non-childbearing potential or of childbearing potential while taking medically appropriate contraception)
- Caucasian
- Age: 21 - 40 years
- BW 50 - 100 kg
- BMI 20 - 26 kg.m-2
Key exclusion criteria (22 listed)
- General - all subjects
- Previous participation in the trial
- Participant in any other trial during the last 90 days
- Donation of blood during the last 60 days or a history of blood loss exceeding 300 mL within the last 3 months
- History of any clinically relevant allergy (including hypersensitivity to the trial medications)
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 |
|---|---|---|
| NRL972Single intravenous administration of 2 mg NRL972 after pre-treatment with 600 mg p.o. rifampicin once daily from the evening of Day D-7 until the evening of Day D-1 | Drug | T1 |
| NRL972Reference test: Single intravenous administration of 2 mg NRL972 | Drug | Reference |
| NRL972Single intravenous administration of 2 mg NRL972 injection after pre-treatment with 100 mg cyclosporine on the evening of Day D-1 and on the morning of Day D01 one hour before administration of NRL972 | Drug | T2 |
Primary outcome
Total clearance by non-compartmental analysis. Apparent terminal disposition half-life t½ by non-compartmental analysis
Time frame: Up to 6 hours post dose
1 secondary outcome
Non-compartmental PK-analysis based on the extensive profile (up to last quantifiable data point), the 'short' profile (over the first hour after injection), and the two-point profile based on selected data-pairs over the 1st hour after dosing
Time frame: Up to 6 hours post dose
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 6 Mar 2009.
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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.
Hans J Gruss, MD study director
Norgine Ltd
Emil Gatchev, PD Dr principal investigator
MHAPT "Zaritza Johanna" University Hospital
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 NRL972 in people with Pharmacokinetics, run by Norgine at 1 site in Bulgaria.
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 7 inclusion and 22 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 6 Mar 2009. 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 Bulgaria. 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?
Total clearance by non-compartmental analysis. Apparent terminal disposition half-life t½ by non-compartmental analysis (time frame: Up to 6 hours post dose). 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 6 Mar 2009.