- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02256774
Study of Pharmacokinetic Interaction Between Combivir® (ZDV+3TC) and BILR 355 BS Plus Ritonavir in Healthy Subjects
2. oktober 2014 opdateret af: Boehringer Ingelheim
Study of Pharmacokinetic Interaction Between Combivir® (ZDV+3TC) and BILR 355 BS Plus Ritonavir
Study to determine the effect of BILR 355/r on Combivir® pharmacokinetics and the effect of Combivir® on BILR 355 BS pharmacokinetics.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
51
Fase
- Fase 1
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
18 år til 59 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Males or females who meet the inclusion/exclusion criteria, females are not pregnant or nursing, and agree to use a double-barrier method of birth control (condoms or diaphragm plus spermicide) throughout the trial (alone or in addition to other methods of birth control such as oral contraceptives)
- Age ≥18 and <60 years
- Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
- Ability to give signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local regulations
Exclusion Criteria:
- Current (symptomatic within the last 30 days) and medically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- Currently active (symptomatic within the last 30 days) diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Intake of drugs with a long half-life (>24 hours) within one month prior to administration of study drug or during the trial (review with clinical monitor if questionable)
- Use of drugs within 10 days prior to administration or during the trial, which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation (review with clinical monitor if questionable)
- Participation in another trial with an investigational drug within one month prior to administration or during the trial
- Current smoker
- Alcohol (more than 60 g/day) or drug abuse (positive urine test for illicit prescription or non-prescription drugs or drugs of abuse).
- Recent blood donation (more than 100 mL within 4 weeks prior to administration or during the trial)
- Excessive physical activities (within 1 week prior to study drug administration or during the trial)
- Any laboratory value outside the normal reference range that is of clinical relevance at screening, according to the judgment of the investigator
- Inability to comply with dietary regimen required by the protocol
- Chronic or relevant acute infections
- Infected with hepatitis B or hepatitis C viruses (defined as either being hepatitis B surface antigen, or hepatitis C antibody positive)
- HIV-1 infected as defined by a positive HIV ELISA test
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Combivir® plus BILR 355/Ritonavir
|
Andre navne:
|
Eksperimentel: BILR 355/Ritonavir
|
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Area under the concentration-time curve of the analyte in plasma over one dosing interval at steady state (AUC0-12h,ss)
Tidsramme: up to day 18
|
up to day 18
|
Maximum measured concentration of the analyte in plasma at steady state over a dosing interval τ (Cmax,ss)
Tidsramme: up to day 18
|
up to day 18
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Apparent clearance of the analyte in plasma following extravascular administration at steady state (CL/F,ss)
Tidsramme: up to day 18
|
up to day 18
|
Time from dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss)
Tidsramme: up to day 18
|
up to day 18
|
Terminal half-life of the analyte in plasma at steady state (t1/2,ss)
Tidsramme: up to day 18
|
up to day 18
|
Apparent volume of distribution during the terminal phase λz at steady state following an extravascular dose (Vz/Fss)
Tidsramme: up to day 18
|
up to day 18
|
Measured concentration of the analyte in plasma 12 hours post last dose at steady state (Cp12h, ss)
Tidsramme: up to day 18
|
up to day 18
|
Number of subjects with adverse events
Tidsramme: up to 49 days
|
up to 49 days
|
Number of subjects with abnormal laboratory parameters
Tidsramme: up to 49 days
|
up to 49 days
|
Number of subjects with clinically significant findings in vital signs
Tidsramme: up to 49 days
|
up to 49 days
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
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. oktober 2004
Primær færdiggørelse (Faktiske)
1. maj 2005
Datoer for studieregistrering
Først indsendt
2. oktober 2014
Først indsendt, der opfyldte QC-kriterier
2. oktober 2014
Først opslået (Skøn)
6. oktober 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
6. oktober 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. oktober 2014
Sidst verificeret
1. oktober 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Antivirale midler
- Reverse transkriptasehæmmere
- Nukleinsyresyntesehæmmere
- Enzymhæmmere
- Anti-HIV-midler
- Anti-retrovirale midler
- Proteasehæmmere
- Cytokrom P-450 CYP3A-hæmmere
- Cytokrom P-450 enzymhæmmere
- HIV-proteasehæmmere
- Virale proteasehæmmere
- Ritonavir
- Lamivudin, zidovudin lægemiddelkombination
Andre undersøgelses-id-numre
- 1188.9
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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