- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00857480
Evaluation of the PK of NRL972 Following Pre- and co-Administration of Ursodeoxycholic Acid and Cloxacillin
6. marts 2009 opdateret af: Norgine
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 B: Interaction With Ursodeoxycholic Acid and Cloxacillin
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
12
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Sofia, Bulgarien, 1431
- MHAPT "Zarita Johanna" University Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
21 år til 40 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
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
- 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 spermicidal gel] should be us
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Reference
No pre-treatment
|
Single intravenous administration of 2 mg NRL972
Pre-treatment and co-treatment with 1 g Cloxacillin t.i.d. for three days from the morning of D-3 until the morning of Day D01 0:30 hour before the intravenous administration of NRL972.
Three week pre-treatment with daily doses of 500 mg b.i.d ursodeoxycholic acid from the morning of D-20 until the evening of Day D-1
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Eksperimentel: T1
Cloxacillin pre- and co-treatment
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Single intravenous administration of 2 mg NRL972
Pre-treatment and co-treatment with 1 g Cloxacillin t.i.d. for three days from the morning of D-3 until the morning of Day D01 0:30 hour before the intravenous administration of NRL972.
Three week pre-treatment with daily doses of 500 mg b.i.d ursodeoxycholic acid from the morning of D-20 until the evening of Day D-1
|
Eksperimentel: T2
UDCA pre-treatment
|
Single intravenous administration of 2 mg NRL972
Pre-treatment and co-treatment with 1 g Cloxacillin t.i.d. for three days from the morning of D-3 until the morning of Day D01 0:30 hour before the intravenous administration of NRL972.
Three week pre-treatment with daily doses of 500 mg b.i.d ursodeoxycholic acid from the morning of D-20 until the evening of Day D-1
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Total clearance by non-compartmental analysis. Apparent terminal disposition half-life t½ by non-compartmental analysis
Tidsramme: 4 hours post-dose
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4 hours post-dose
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
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
Tidsramme: 4 hours post-dose
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4 hours post-dose
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Emil Gatchev, PD Dr med, MHAPT "Zarita Johanna" University Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2006
Primær færdiggørelse (Faktiske)
1. august 2006
Studieafslutning (Faktiske)
1. oktober 2006
Datoer for studieregistrering
Først indsendt
5. marts 2009
Først indsendt, der opfyldte QC-kriterier
5. marts 2009
Først opslået (Skøn)
6. marts 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
9. marts 2009
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. marts 2009
Sidst verificeret
1. marts 2009
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NRL972-05/2005 (IN-B)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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