Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Canagliflozin (JNJ-28431754) in Otherwise Healthy Obese Volunteers
11. desember 2018 oppdatert av: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
A Double-Blind, Randomized, Placebo-Controlled, Sequential Cohort Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of JNJ-28431754 in Otherwise Healthy Obese Male and Female Subjects
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 increasing doses of canagliflozin (JNJ-28431754) in healthy obese volunteers.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This study will be a single-center, randomized (the treatment is assigned by chance), double-blind (neither investigator nor volunteer knows the identity of the assigned treatment), placebo-controlled (one of the study medications is inactive), ascending multiple dose study (increasing doses of study medication) to assess the pharmacokinetics and pharmacodynamics of canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus) in otherwise healthy obese volunteers.
The study will consist of 3 phases: a screening phase, a double-blind treatment phase, and an end of study (or follow-up) phase.
Volunteers will be assigned to 5 cohorts (groups) made up of 16 otherwise healthy obese men and women.
Within each group, 12 volunteers will be given canagliflozin once or twice daily and 4 volunteers will be given placebo (inactive medication) once or twice daily for 14 days.
The dose of canagliflozin will be different for each of the 5 groups and the second group will not begin treatment until at least 21 days after the first group start treatment.
This 21-day gap will be applied to all subsequent groups.
Each volunteer will participate in the study for approximately 58 days.
Studietype
Intervensjonell
Registrering (Faktiske)
80
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Florida
-
Miramar, Florida, Forente stater
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 60 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Volunteers must have a body mass index (BMI = weight in kg/height in m2) of 30.0 to 39.9 kg/m2
- Volunteers must be non-diabetic as confirmed by fasting plasma glucose <126 mg/dL
- Volunteers must be non-smoker or non-tobacco users (not smoked cigarettes or used tobacco-containing products for 3 months prior to screening)
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
- History of having taken anti-obesity medications (prescription or non-prescription) within 3 months of the screening visit, or anticipates a need to take any of these drugs during the course of the study
- History of gastric banding, gastric bypass or other gastric-reduction surgery
- History of eating disorder or recent significant changes in body weight due to dieting or nutritional treatment
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Cohort 1
Each volunteer will receive a total daily dose of 30 mg of canagliflozin (JNJ-28431754) or placebo (inactive medication) on Days 1 through 14.
|
A 30mg/day, 100 mg/day, 300 mg/day, or 600 mg/day liquid dose administered once daily; a 300mg/day liquid dose administered in 2 divided doses (2x150 mg); or a 600 mg/day liquid dose administered in 2 divided doses (2x300 mg) using an oral (by mouth) liquid dispenser on Days 1 through 14.
Andre navn:
Matching placebo (inactive medication) liquid dose(s) administered using an oral liquid dispenser once or twice daily on Days 1 through 14.
|
|
Eksperimentell: Cohort 2
Each volunteer will receive a total daily dose of 100 mg of canagliflozin (JNJ-28431754) or placebo (inactive medication) on Days 1 through 14.
|
A 30mg/day, 100 mg/day, 300 mg/day, or 600 mg/day liquid dose administered once daily; a 300mg/day liquid dose administered in 2 divided doses (2x150 mg); or a 600 mg/day liquid dose administered in 2 divided doses (2x300 mg) using an oral (by mouth) liquid dispenser on Days 1 through 14.
Andre navn:
Matching placebo (inactive medication) liquid dose(s) administered using an oral liquid dispenser once or twice daily on Days 1 through 14.
|
|
Eksperimentell: Cohort 3
Each volunteer will receive a total daily dose of 300 mg of canagliflozin (JNJ-28431754) or placebo (inactive medication) on Days 1 through 14.
|
A 30mg/day, 100 mg/day, 300 mg/day, or 600 mg/day liquid dose administered once daily; a 300mg/day liquid dose administered in 2 divided doses (2x150 mg); or a 600 mg/day liquid dose administered in 2 divided doses (2x300 mg) using an oral (by mouth) liquid dispenser on Days 1 through 14.
Andre navn:
Matching placebo (inactive medication) liquid dose(s) administered using an oral liquid dispenser once or twice daily on Days 1 through 14.
|
|
Eksperimentell: Cohort 4
Each volunteer will receive a total daily dose of 600 mg of canagliflozin (JNJ-28431754) or placebo (inactive medication) on Days 1 through 14.
|
A 30mg/day, 100 mg/day, 300 mg/day, or 600 mg/day liquid dose administered once daily; a 300mg/day liquid dose administered in 2 divided doses (2x150 mg); or a 600 mg/day liquid dose administered in 2 divided doses (2x300 mg) using an oral (by mouth) liquid dispenser on Days 1 through 14.
Andre navn:
Matching placebo (inactive medication) liquid dose(s) administered using an oral liquid dispenser once or twice daily on Days 1 through 14.
|
|
Eksperimentell: Cohort 5
Each volunteer will receive 300 mg of canagliflozin (JNJ-28431754) twice daily (600 mg total daily dose) or placebo (inactive medication) twice daily on Days 1 through 14.
|
A 30mg/day, 100 mg/day, 300 mg/day, or 600 mg/day liquid dose administered once daily; a 300mg/day liquid dose administered in 2 divided doses (2x150 mg); or a 600 mg/day liquid dose administered in 2 divided doses (2x300 mg) using an oral (by mouth) liquid dispenser on Days 1 through 14.
Andre navn:
Matching placebo (inactive medication) liquid dose(s) administered using an oral liquid dispenser once or twice daily on Days 1 through 14.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in urine glucose excretion per day
Tidsramme: Day -1 (Baseline) up to Day 17
|
The change from baseline in urine excretion per day will be compared following escalating doses of canagliflozin (JNJ-28431754).
|
Day -1 (Baseline) up to Day 17
|
|
Change from baseline in urine glucose excretion per hour
Tidsramme: Day -1 (Baseline) up to Day 17
|
The change from baseline in urine excretion per hour will be compared following escalating doses of canagliflozin (JNJ-28431754).
|
Day -1 (Baseline) up to Day 17
|
|
Visual analog scale (VAS) scores related to hunger, satiety, fullness and prospective food consumption
Tidsramme: Day -2 up to Day 17
|
Visual analog scale (VAS) scores will be obtained from the VAS questionnaire.
In the VAS questionnaire, volunteers mark a point on a line (drawn between 2 statements) to indicate how they feel about the statements.
The statements about hunger are as follows: "I am not hungry at all" and "I have never been hungrier".
Other statements relate to satiety (feeling satisfied), feeling full and prospective food consumption.
Scores will be compared following escalating doses of canagliflozin (JNJ-28431754).
|
Day -2 up to Day 17
|
|
Change from baseline in mean 24-hour plasma glucose concentrations
Tidsramme: Day -1 (Baseline) up to Day 16
|
The change from baseline in mean 24-hour plasma glucose concentrations will be compared following escalating doses of canagliflozin (JNJ-28431754).
|
Day -1 (Baseline) up to Day 16
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Renal threshold for glucose excretion
Tidsramme: Up to Day 17
|
The point at which glucose starts to appear in the urine is known as the renal threshold.
The way in which the renal threshold varies in relation to the dose of canagliflozin (JNJ-28431754) will be calculated.
|
Up to Day 17
|
|
Change from baseline in mean 24-hour plasma insulin concentrations
Tidsramme: Day -1 (Baseline) up to Day 14
|
The change from baseline in mean 24-hour plasma insulin concentrations will be compared following escalating doses of canagliflozin (JNJ-28431754).
|
Day -1 (Baseline) up to Day 14
|
|
Change from baseline in mean 24-hour plasma C-peptide concentrations
Tidsramme: Day -1 (Baseline) up to Day 14
|
The change from baseline in mean 24-hour plasma C-peptide concentrations will be compared following escalating doses of canagliflozin (JNJ-28431754).
|
Day -1 (Baseline) up to Day 14
|
|
Change from baseline in glucose excursions (after breakfast)
Tidsramme: Day -1 (Baseline) up to Day 14
|
Defined as the difference between the maximum glucose values observed during the 4-hour post-meal period minus the mean of the premeal measurements.
Results will be compared following escalating doses of canagliflozin (JNJ-28431754).
|
Day -1 (Baseline) up to Day 14
|
|
Change from baseline in insulin excursions (after breakfast)
Tidsramme: Day -1 (Baseline) up to Day 14
|
Defined as the difference between the maximum insulin values observed during the 4-hour post-meal period minus the mean of the premeal measurements.
Results will be compared following escalating doses of canagliflozin (JNJ-28431754).
|
Day -1 (Baseline) up to Day 14
|
|
Change from baseline in beta cell function
Tidsramme: Day -1 (Baseline) up to Day 14
|
Beta cell function will be calculated from the glucose, insulin, and C-peptide measurements taken post-breakfast on Day -1 up to Day 14. Results will be compared following escalating doses of canagliflozin (JNJ-28431754).
|
Day -1 (Baseline) up to Day 14
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Publikasjoner og nyttige lenker
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
14. juni 2007
Primær fullføring (Faktiske)
5. desember 2007
Studiet fullført (Faktiske)
5. desember 2007
Datoer for studieregistrering
Først innsendt
20. desember 2012
Først innsendt som oppfylte QC-kriteriene
20. desember 2012
Først lagt ut (Anslag)
25. desember 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
13. desember 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. desember 2018
Sist bekreftet
1. desember 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CR013765
- 28431754NAP1008 (Annen identifikator: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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