A Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Canagliflozin (JNJ-28431754) in Volunteers With Varying Degrees of Kidney Function
27 maj 2013 uppdaterad av: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
An Open-Label, Single-Dose Study to Evaluate JNJ-28431754 Pharmacokinetics, Pharmacodynamics and Safety in Non-Diabetic Subjects With Varying Degrees of Renal Function
The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how the drug affects the body) of canagliflozin (JNJ-28431754) after administration of a single dose to non-diabetic volunteers with normal kidney function and non-diabetic volunteers with varying degrees of kidney impairment (including volunteers with end-stage renal disease requiring hemodialysis).
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This study will be an open label (all volunteers and study staff know the identity of the assigned treatment), single-dose, multicenter (the study will be conducted at more than one center), parallel-group study (each group of volunteers will be treated at the same time) to assess the pharmacokinetics and pharmacodynamics of canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus) in volunteers with varying degrees of kidney function.
The study will consist of 3 phases: a screening phase, an open-label treatment phase, and an end-of study (or follow-up) phase.
Volunteers will be assigned to 1 of 5 groups (depending on kidney function): group 1 will have normal kidney function; group 2 will have mild kidney impairment; group 3 will have moderate kidney impairment; group 4 will have severe kidney impairment; and group 5 will comprise volunteers requiring hemodialysis.
Volunteers in groups 1 through 4 will receive a single dose of canagliflozin on Day 1. Volunteers in group 5 will receive a single dose of canagliflozin following dialysis and then, approximately 10 days later, they will receive a second dose before dialysis.
Volunteers in groups 1 through 4 will participate in the study for 27 days.
Volunteers in group 5 will participate in the study for 40 days.
Studietyp
Interventionell
Inskrivning (Faktisk)
40
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Florida
-
Orlando, Florida, Förenta staterna
-
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Minnesota
-
Minneapolis, Minnesota, Förenta staterna
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-
Tennessee
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Knoxville, Tennessee, Förenta staterna
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 79 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Volunteers must have a body mass index (BMI = weight in kg/height in m2) between 20 and 40 kg/m2 (inclusive), and body weight not less than 50 kg
- Volunteers must smoke no more than 10 cigarettes, or 2 cigars, or 2 pipes of tobacco per day for at least 6 months before first study drug administration
Exclusion Criteria:
- History of or currently active illness considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results
- Volunteers with end stage renal disease receiving dialysis treatment other than intermittent hemodialysis
- Volunteers with end stage renal disease who have received a renal transplantation within 1 year before screening
- Volunteers with end stage renal disease diagnosed with renal carcinoma within 1 year before screening
- Volunteers with end stage renal disease receiving immunosuppressive medications, including steroids
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Group 1 (normal kidney function)
Each volunteer will receive a single dose of canagliflozin (JNJ-28431754) on Day 1
|
Volunteers in groups 1 through 4 will receive one 200mg tablet orally (by mouth) on Day 1. Volunteers in group 5 will receive one 200mg tablet orally on Day 1 (one hour after hemodialysis) followed, approximately 10 days later, by one 200mg tablet orally (2 hours before hemodialysis).
Andra namn:
|
|
Experimentell: Group 2 (mild kidney impairment)
Each volunteer will receive a single dose of canagliflozin (JNJ-28431754) on Day 1
|
Volunteers in groups 1 through 4 will receive one 200mg tablet orally (by mouth) on Day 1. Volunteers in group 5 will receive one 200mg tablet orally on Day 1 (one hour after hemodialysis) followed, approximately 10 days later, by one 200mg tablet orally (2 hours before hemodialysis).
Andra namn:
|
|
Experimentell: Group 3 (moderate kidney impairment)
Each volunteer will receive a single dose of canagliflozin (JNJ-28431754) on Day 1
|
Volunteers in groups 1 through 4 will receive one 200mg tablet orally (by mouth) on Day 1. Volunteers in group 5 will receive one 200mg tablet orally on Day 1 (one hour after hemodialysis) followed, approximately 10 days later, by one 200mg tablet orally (2 hours before hemodialysis).
Andra namn:
|
|
Experimentell: Group 4 (severe kidney impairment)
Each volunteer will receive a single dose of canagliflozin (JNJ-28431754) on Day 1
|
Volunteers in groups 1 through 4 will receive one 200mg tablet orally (by mouth) on Day 1. Volunteers in group 5 will receive one 200mg tablet orally on Day 1 (one hour after hemodialysis) followed, approximately 10 days later, by one 200mg tablet orally (2 hours before hemodialysis).
Andra namn:
|
|
Experimentell: Group 5 (hemodialysis)
Each volunteer will receive a single dose of canagliflozin (JNJ-28431754) on Day 1 following completion of hemodialysis.
Approximately 10 days later, each volunteer will receive another single dose of canagliflozin before hemodialysis begins.
|
Volunteers in groups 1 through 4 will receive one 200mg tablet orally (by mouth) on Day 1. Volunteers in group 5 will receive one 200mg tablet orally on Day 1 (one hour after hemodialysis) followed, approximately 10 days later, by one 200mg tablet orally (2 hours before hemodialysis).
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Plasma concentrations of canagliflozin (JNJ-28431754) in varying degrees of kidney function
Tidsram: Up to Day 6
|
Plasma concentrations of canagliflozin (JNJ-28431754) following the administration of a single dose of canagliflozin will be used to determine pharmacokinetic parameters for canagliflozin (measurements describing how the body affects the drug) in varying degrees of kidney function.
|
Up to Day 6
|
|
Change from baseline in 24-hour urine glucose excretion in varying degrees of kidney function
Tidsram: Day -1 (Baseline) to Day 3
|
Change from baseline in 24-hour urine glucose excretion following the administration of a single dose of canagliflozin (JNJ-28431754) will be used to evaluate the pharmacodynamics of canagliflozin (ie, how the drug affects the body) in varying degrees of kidney function.
|
Day -1 (Baseline) to Day 3
|
|
Plasma concentrations of canagliflozin (JNJ-28431754) metabolites in varying degrees of kidney function
Tidsram: Up to Day 6
|
Plasma concentrations of canagliflozin (JNJ-28431754) metabolites following the administration of a single dose of canagliflozin will be used to determine pharmacokinetic parameters for canagliflozin metabolites (measurements describing how the body affects the metabolites) in varying degrees of kidney function.
|
Up to Day 6
|
Samarbetspartners och utredare
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Publikationer och användbara länkar
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 mars 2008
Primärt slutförande (Faktisk)
1 november 2008
Avslutad studie (Faktisk)
1 november 2008
Studieregistreringsdatum
Först inskickad
24 december 2012
Först inskickad som uppfyllde QC-kriterierna
28 december 2012
Första postat (Uppskatta)
3 januari 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
29 maj 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 maj 2013
Senast verifierad
1 maj 2013
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CR014761
- 28431754DIA1003 (Annan identifierare: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.)
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