- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00866515
Drug Interaction Study to Investigate Co-administration of GW642444M With Ketoconazole
13. juli 2017 opdateret af: GlaxoSmithKline
A Double-blind, Placebo-controlled, Randomised, 2-way Crossover Drug Interaction Study to Investigate the Pharmacokinetic and Pharmacodynamic Effects Following Co-administration of GW642444M With Ketoconazole
This will be a single-centre, randomised, double blind, placebo controlled, two-way crossover study in healthy male and female subjects.
There will be two treatment periods each consisting of 7 days.
During each treatment period subjects will receive single doses of ketoconazole or placebo on the morning of days 1-6 with a single dose of GW642444M on the morning of Day 5.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This will be a single-centre, randomised, double blind, placebo controlled, two-way crossover study in healthy male and female subjects.
There will be two treatment periods each consisting of 7 days.
During each treatment period subjects will receive single doses of ketoconazole or placebo on the morning of days 1-6 with a single dose of GW642444M on the morning of Day 5.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
20
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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New South Wales
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Randwick, New South Wales, Australien, 2031
- GSK Investigational Site
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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
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included at the discretion of the Investigator only if the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- A female subject is eligible to participate if she is of:
- Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation, hysterectomy or bilateral oophorectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in Section 8.1 if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.
- Child-bearing potential and agrees to use one of the contraception methods listed in Section 8.1 for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until after the final follow-up visit has been completed.
- Body weight ≥ 50 kg and BMI within the range 19 - 29.9 kg/m2 (inclusive).
- Demonstrated ability to use the inhaler device in a satisfactory and repeatable manner
- Subjects who are current non-smokers, who have not used any inhaled tobacco products (snuff is permitted) in the 12 month period preceding the screening visit and who have a pack history of ≤ 10 pack years.
- No significant abnormality on 12-lead ECG at screening, including the following requirements:
- Ventricular rate ≥ 40 beats per minute
- PR interval ≥ 120 and ≤ 210 msec
- Q waves < 30 msec (up to 50 msec permitted in lead III only)
- QRS interval to be ≥ 60 msec and ≤ 120 msec
- QTc interval must be < 450 msec (QTcB or QTcF; machine or manual reading) based on an average from three ECGs obtained over a brief recording period
- FEV1 ≥ 80% predicted and a FEV1 / FVC ratio ≥ 0.7 at screening
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Exclusion Criteria:
- As a result of medical interview, physical examination or screening investigations, the principle investigator or delegate physician deems the subject unsuitable for the study.
- Systolic blood pressure which is outside the range 90 to 140 mmHg, diastolic blood pressure outside the range 50 to 90 mmHg or heart rate outside the range 40 to 90 bpm.
- The subject has been treated for or diagnosed with depression within six months of screening or has a history of significant psychiatric illness.
- The subject has any history of breathing problems in adult life (i.e. history of asthmatic symptomatology).
- A clinically significant abnormality on standard pulmonary function testing, or any other finding that would prevent satisfactory administration of the inhaled study medication.
- Any contraindication to the administration of ketoconazole, as described in the current [NIZORAL Product Information, Janssen-Cilag Pty Limited, 2008].
- History of sensitivity to any of the study medications, or components thereof (including milk protein) or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Currently taking regular (or a course of) medication whether prescribed or not, with the exception of those permitted medications listed in Section 8.1 and Section 9.1.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- History of regular alcohol consumption within 6 months of the study defined as:
- An average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (~250 mL) of beer, 1 glass (100 mL) of wine or 1 measure (30 mL) of spirits.
- The subject has participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication.
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- The subject has donated a unit of blood within the previous 16 weeks or intends to donate within 16 weeks after completing the study.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- The subject has tested positive for HIV antibodies.
- The subject has a positive pre-study urine drug screen/ alcohol breath test. A minimum list of drugs that will be screened for include Amphetamines, Barbiturates, Cocaine, Opiates, Cannabinoids and Benzodiazepines.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subjects who have a screening haemoglobin value < 110 mg/L.
- Pregnant (as determined by positive (serum or urine) hCG test at screening or prior to dosing) or lactating females.
- Subject is mentally or legally incapacitated.
- CO breath monitoring indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.
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: Crossover opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Active
Ketoconazole 400mg OD days 1-6
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Ketoconazole 400mg OD days 1-6, GW642444M 25ug single dose on D5
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Placebo komparator: Placebo
Placebo OD for 1 to 6 days
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Placebo to match D1-6 + GW642444M 25ug single dose on D5
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Supine heart rate and blood potassium levels
Tidsramme: Day 5
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Day 5
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Plasma GW642444M concentrations
Tidsramme: Day 5
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Day 5
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Reported Adverse Events
Tidsramme: treatment periods
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treatment periods
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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.
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 (Faktiske)
22. december 2008
Primær færdiggørelse (Faktiske)
27. marts 2009
Studieafslutning (Faktiske)
27. marts 2009
Datoer for studieregistrering
Først indsendt
22. januar 2009
Først indsendt, der opfyldte QC-kriterier
19. marts 2009
Først opslået (Skøn)
20. marts 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. juli 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. juli 2017
Sidst verificeret
1. juli 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Luftvejssygdomme
- Lungesygdomme
- Lungesygdomme, obstruktiv
- Lungesygdom, kronisk obstruktiv
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Enzymhæmmere
- Hormoner, hormonsubstitutter og hormonantagonister
- Cytokrom P-450 CYP3A-hæmmere
- Cytokrom P-450 enzymhæmmere
- Hormonantagonister
- Antifungale midler
- Steroidsyntesehæmmere
- 14-alfa-demethylasehæmmere
- Ketoconazol
Andre undersøgelses-id-numre
- 112205
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Studiedata/dokumenter
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Formular til informeret samtykke
Informations-id: 112205Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Individuelt deltagerdatasæt
Informations-id: 112205Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Statistisk analyseplan
Informations-id: 112205Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Datasætspecifikation
Informations-id: 112205Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Annoteret sagsbetænkningsformular
Informations-id: 112205Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Studieprotokol
Informations-id: 112205Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Klinisk undersøgelsesrapport
Informations-id: 112205Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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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