A Study of MK-0893 on Glucagon-Induced Glycemic Excursion in Healthy Male Participants Following Intravenous Administration of Glucagon, Sandostatine® and Insulin (MK-0893-002)
18. august 2015 oppdatert av: Merck Sharp & Dohme LLC
A Double-Blind, Randomized, Placebo-Controlled, Single-Dose, 3-Period, 4 Treatment Incomplete Crossover Study to Assess the Effects of Single Oral Doses of L-001241689 on Glucagon-Induced Glycemic Excursion in Healthy Male Subjects Following Intravenous Administration of Glucagon, Sandostatine® and Insulin
This is a study to assess the pharmacokinetics, safety, and tolerability of sequential single oral doses of MK-8093 10 mg, 40 mg, 200 mg, or placebo to MK-8093 (Part 1) depending on treatment assignment in young healthy male participants.
In Part 2 of this study, sequential single oral doses of MK-8093 200 mg, 1000 mg or placebo to MK-8093 depending on treatment assignment will be evaluated.
The primary hypothesis of the study is that at least one dose of MK-0893 will produce greater reduction of glucagon-induced glycemia as compared to placebo following the infusion of glucagon, Sandostatine®, and basal insulin.
Studieoversikt
Status
Fullført
Forhold
Studietype
Intervensjonell
Registrering (Faktiske)
18
Fase
- Fase 1
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 50 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Mann
Beskrivelse
Inclusion Criteria:
- Good health
- Body Mass Index of between 18 and 28 kg/m^2, or up to 30 kg/m^2 with approval of sponsor
- Non-smoker for at least 6 months
- Willing to avoid strenuous physical activity
- Willing to avoid alcohol, caffeine, and grapefruit juice consumption
Exclusion Criteria:
- History of renal, neurologic, gastrointestinal or respiratory disease or any gastrointestinal surgery
- History of multiple and/or severe allergies to a prescription, nonprescription or investigational drug or food
- History of any cardiovascular/cardiac disease
- History of any hepatic disease and primary biliary cirrhosis
- History of hypoglycemia or glucose intolerance, type 1 diabetes, or type 2 diabetes
- Requires or anticipates use of prescription or nonprescription medications, including herbal remedies
- A user of any illicit drugs or a history of drug or alcohol abuse
- Surgery, donated a unit of blood, or participated in another clinical study within 4 weeks prior to study participation
- History of hypersensitivity to insulin, glucagon, or Sandostatine®.
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: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: MK-0893 40 mg→MK-0893 200 mg→placebo
In Part 1 of the study, participants receive MK-0893 (10 mg, 40 mg or 200 mg) or placebo on Day 1 of each period, and Sandostatine® (30 ng/kg/min), insulin (0.10 mIU/kg/min), and glucagon (3 ng/kg/min) at 24 and 72 hours post dose.
In Part 2 of the study, participants receive MK-0893 (200 mg or 1000 mg) or placebo on Day 1 of each period and Sandostatine®, insulin, and glucagon at 120 hours post dose.
There will be at least 21 days between administrations of study drugs.
|
MK-0893 40 mg administered orally in 240 mL of water
MK-0893 200 mg administered orally in 240 mL of water
Placebo administered orally in 240 mL of water
Sandostatine® is a somatostatin analogue.
At 24 and at 72 (Part I) or 120 (Part II) hours postdose, simultaneous infusions of the Sandostatine®, insulin, and glucagon will be administered over a 2-hour period.
These compounds are IV compatible and will be combined in one syringe.
Intravenous Sandostatine® will be administered at 30 ng/kg/min.
Andre navn:
At 24 and at 72 (Part I) or 120 (Part II) hours postdose, simultaneous infusions of the Sandostatine®, insulin, and glucagon will be administered over a 2-hour period.
These compounds are IV compatible and will be combined in one syringe.
Intravenous insulin will be administered at 0.10 milli-international unit (mIU)/kg/min.
Andre navn:
At 24 and at 72 (Part I) or 120 (Part II) hours postdose, simultaneous infusions of the Sandostatine®, insulin, and glucagon will be administered over a 2-hour period.
These compounds are IV compatible and will be combined in one syringe.
Intravenous glucagon will be administered at 3 ng/kg/min.
Andre navn:
|
|
Eksperimentell: MK-0893 200 mg→placebo→MK-0893 10 mg
In Part 1 of the study, participants receive MK-0893 (10 mg, 40 mg or 200 mg) or placebo on Day 1 of each period, and Sandostatine® (30 ng/kg/min), insulin (0.10 mIU/kg/min), and glucagon (3 ng/kg/min) at 24 and 72 hours post dose.
In Part 2 of the study, participants receive MK-0893 (200 mg or 1000 mg) or placebo on Day 1 of each period and Sandostatine®, insulin, and glucagon at 120 hours post dose.
There will be at least 21 days between administrations of study drugs.
|
MK-0893 200 mg administered orally in 240 mL of water
Placebo administered orally in 240 mL of water
Sandostatine® is a somatostatin analogue.
At 24 and at 72 (Part I) or 120 (Part II) hours postdose, simultaneous infusions of the Sandostatine®, insulin, and glucagon will be administered over a 2-hour period.
These compounds are IV compatible and will be combined in one syringe.
Intravenous Sandostatine® will be administered at 30 ng/kg/min.
Andre navn:
At 24 and at 72 (Part I) or 120 (Part II) hours postdose, simultaneous infusions of the Sandostatine®, insulin, and glucagon will be administered over a 2-hour period.
These compounds are IV compatible and will be combined in one syringe.
Intravenous insulin will be administered at 0.10 milli-international unit (mIU)/kg/min.
Andre navn:
At 24 and at 72 (Part I) or 120 (Part II) hours postdose, simultaneous infusions of the Sandostatine®, insulin, and glucagon will be administered over a 2-hour period.
These compounds are IV compatible and will be combined in one syringe.
Intravenous glucagon will be administered at 3 ng/kg/min.
Andre navn:
MK-0893 10 mg administered orally in 240 mL of water
|
|
Eksperimentell: Placebo→MK-0893 10 mg→MK-0893 40 mg
In Part 1 of the study, participants receive MK-0893 (10 mg, 40 mg or 200 mg) or placebo on Day 1 of each period, and Sandostatine® (30 ng/kg/min), insulin (0.10 mIU/kg/min), and glucagon (3 ng/kg/min) at 24 and 72 hours post dose.
In Part 2 of the study, participants receive MK-0893 (200 mg or 1000 mg) or placebo on Day 1 of each period and Sandostatine®, insulin, and glucagon at 120 hours post dose.
There will be at least 21 days between administrations of study drugs.
|
MK-0893 40 mg administered orally in 240 mL of water
Placebo administered orally in 240 mL of water
Sandostatine® is a somatostatin analogue.
At 24 and at 72 (Part I) or 120 (Part II) hours postdose, simultaneous infusions of the Sandostatine®, insulin, and glucagon will be administered over a 2-hour period.
These compounds are IV compatible and will be combined in one syringe.
Intravenous Sandostatine® will be administered at 30 ng/kg/min.
Andre navn:
At 24 and at 72 (Part I) or 120 (Part II) hours postdose, simultaneous infusions of the Sandostatine®, insulin, and glucagon will be administered over a 2-hour period.
These compounds are IV compatible and will be combined in one syringe.
Intravenous insulin will be administered at 0.10 milli-international unit (mIU)/kg/min.
Andre navn:
At 24 and at 72 (Part I) or 120 (Part II) hours postdose, simultaneous infusions of the Sandostatine®, insulin, and glucagon will be administered over a 2-hour period.
These compounds are IV compatible and will be combined in one syringe.
Intravenous glucagon will be administered at 3 ng/kg/min.
Andre navn:
MK-0893 10 mg administered orally in 240 mL of water
|
|
Eksperimentell: MK-0893 10 mg→MK-0893 40 mg→MK-0893 200 mg
In Part 1 of the study, participants receive MK-0893 (10 mg, 40 mg or 200 mg) or placebo on Day 1 of each period, and Sandostatine® (30 ng/kg/min), insulin (0.10 mIU/kg/min), and glucagon (3 ng/kg/min) at 24 and 72 hours post dose.
In Part 2 of the study, participants receive MK-0893 (200 mg or 1000 mg) or placebo on Day 1 of each period and Sandostatine®, insulin, and glucagon at 120 hours post dose.
There will be at least 21 days between administrations of study drugs.
|
MK-0893 40 mg administered orally in 240 mL of water
MK-0893 200 mg administered orally in 240 mL of water
Sandostatine® is a somatostatin analogue.
At 24 and at 72 (Part I) or 120 (Part II) hours postdose, simultaneous infusions of the Sandostatine®, insulin, and glucagon will be administered over a 2-hour period.
These compounds are IV compatible and will be combined in one syringe.
Intravenous Sandostatine® will be administered at 30 ng/kg/min.
Andre navn:
At 24 and at 72 (Part I) or 120 (Part II) hours postdose, simultaneous infusions of the Sandostatine®, insulin, and glucagon will be administered over a 2-hour period.
These compounds are IV compatible and will be combined in one syringe.
Intravenous insulin will be administered at 0.10 milli-international unit (mIU)/kg/min.
Andre navn:
At 24 and at 72 (Part I) or 120 (Part II) hours postdose, simultaneous infusions of the Sandostatine®, insulin, and glucagon will be administered over a 2-hour period.
These compounds are IV compatible and will be combined in one syringe.
Intravenous glucagon will be administered at 3 ng/kg/min.
Andre navn:
MK-0893 10 mg administered orally in 240 mL of water
|
|
Eksperimentell: Placebo→MK-0893 1000 mg→MK-0893 200 mg
In Part 1 of the study, participants receive MK-0893 (10 mg, 40 mg or 200 mg) or placebo on Day 1 of each period, and Sandostatine® (30 ng/kg/min), insulin (0.10 mIU/kg/min), and glucagon (3 ng/kg/min) at 24 and 72 hours post dose.
In Part 2 of the study, participants receive MK-0893 (200 mg or 1000 mg) or placebo on Day 1 of each period and Sandostatine®, insulin, and glucagon at 120 hours post dose.
There will be at least 21 days between administrations of study drugs.
|
MK-0893 200 mg administered orally in 240 mL of water
Placebo administered orally in 240 mL of water
Sandostatine® is a somatostatin analogue.
At 24 and at 72 (Part I) or 120 (Part II) hours postdose, simultaneous infusions of the Sandostatine®, insulin, and glucagon will be administered over a 2-hour period.
These compounds are IV compatible and will be combined in one syringe.
Intravenous Sandostatine® will be administered at 30 ng/kg/min.
Andre navn:
At 24 and at 72 (Part I) or 120 (Part II) hours postdose, simultaneous infusions of the Sandostatine®, insulin, and glucagon will be administered over a 2-hour period.
These compounds are IV compatible and will be combined in one syringe.
Intravenous insulin will be administered at 0.10 milli-international unit (mIU)/kg/min.
Andre navn:
At 24 and at 72 (Part I) or 120 (Part II) hours postdose, simultaneous infusions of the Sandostatine®, insulin, and glucagon will be administered over a 2-hour period.
These compounds are IV compatible and will be combined in one syringe.
Intravenous glucagon will be administered at 3 ng/kg/min.
Andre navn:
MK-0893 1000 mg administered orally in 240 mL of water
|
|
Eksperimentell: MK-0893 200 mg→placebo→MK-0893 1000 mg
In Part 1 of the study, participants receive MK-0893 (10 mg, 40 mg or 200 mg) or placebo on Day 1 of each period, and Sandostatine® (30 ng/kg/min), insulin (0.10 mIU/kg/min), and glucagon (3 ng/kg/min) at 24 and 72 hours post dose.
In Part 2 of the study, participants receive MK-0893 (200 mg or 1000 mg) or placebo on Day 1 of each period and Sandostatine®, insulin, and glucagon at 120 hours post dose.
There will be at least 21 days between administrations of study drugs.
|
MK-0893 200 mg administered orally in 240 mL of water
Placebo administered orally in 240 mL of water
Sandostatine® is a somatostatin analogue.
At 24 and at 72 (Part I) or 120 (Part II) hours postdose, simultaneous infusions of the Sandostatine®, insulin, and glucagon will be administered over a 2-hour period.
These compounds are IV compatible and will be combined in one syringe.
Intravenous Sandostatine® will be administered at 30 ng/kg/min.
Andre navn:
At 24 and at 72 (Part I) or 120 (Part II) hours postdose, simultaneous infusions of the Sandostatine®, insulin, and glucagon will be administered over a 2-hour period.
These compounds are IV compatible and will be combined in one syringe.
Intravenous insulin will be administered at 0.10 milli-international unit (mIU)/kg/min.
Andre navn:
At 24 and at 72 (Part I) or 120 (Part II) hours postdose, simultaneous infusions of the Sandostatine®, insulin, and glucagon will be administered over a 2-hour period.
These compounds are IV compatible and will be combined in one syringe.
Intravenous glucagon will be administered at 3 ng/kg/min.
Andre navn:
MK-0893 1000 mg administered orally in 240 mL of water
|
|
Eksperimentell: MK-0893 1000 mg→MK-0893 200 mg→placebo
In Part 1 of the study, participants receive MK-0893 (10 mg, 40 mg or 200 mg) or placebo on Day 1 of each period, and Sandostatine® (30 ng/kg/min), insulin (0.10 mIU/kg/min), and glucagon (3 ng/kg/min) at 24 and 72 hours post dose.
In Part 2 of the study, participants receive MK-0893 (200 mg or 1000 mg) or placebo on Day 1 of each period and Sandostatine®, insulin, and glucagon at 120 hours post dose.
There will be at least 21 days between administrations of study drugs.
|
MK-0893 200 mg administered orally in 240 mL of water
Placebo administered orally in 240 mL of water
Sandostatine® is a somatostatin analogue.
At 24 and at 72 (Part I) or 120 (Part II) hours postdose, simultaneous infusions of the Sandostatine®, insulin, and glucagon will be administered over a 2-hour period.
These compounds are IV compatible and will be combined in one syringe.
Intravenous Sandostatine® will be administered at 30 ng/kg/min.
Andre navn:
At 24 and at 72 (Part I) or 120 (Part II) hours postdose, simultaneous infusions of the Sandostatine®, insulin, and glucagon will be administered over a 2-hour period.
These compounds are IV compatible and will be combined in one syringe.
Intravenous insulin will be administered at 0.10 milli-international unit (mIU)/kg/min.
Andre navn:
At 24 and at 72 (Part I) or 120 (Part II) hours postdose, simultaneous infusions of the Sandostatine®, insulin, and glucagon will be administered over a 2-hour period.
These compounds are IV compatible and will be combined in one syringe.
Intravenous glucagon will be administered at 3 ng/kg/min.
Andre navn:
MK-0893 1000 mg administered orally in 240 mL of water
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Post-infusion Incremental Glucose Area Under the Plasma Concentration Versus Time Curve [AUC0-240 min] Study Part 1
Tidsramme: Up to 76 hours postdose
|
Up to 76 hours postdose
|
|
Post-infusion Incremental Glucose Area Under the Plasma Concentration Versus Time Curve [AUC0-240 min] Study Part 2
Tidsramme: Up to 124 hours postdose
|
Up to 124 hours postdose
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Number of Participants With An Adverse Event (AE)
Tidsramme: Up to 12 weeks
|
Up to 12 weeks
|
|
Number of Participants Who Discontinued Study Treatment Due To AEs
Tidsramme: Up to 21 days of each treatment period
|
Up to 21 days of each treatment period
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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
1. juli 2005
Primær fullføring (Faktiske)
1. desember 2005
Studiet fullført (Faktiske)
1. desember 2005
Datoer for studieregistrering
Først innsendt
3. desember 2013
Først innsendt som oppfylte QC-kriteriene
10. desember 2013
Først lagt ut (Anslag)
16. desember 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
19. august 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. august 2015
Sist bekreftet
1. august 2015
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Glukosemetabolismeforstyrrelser
- Metabolske sykdommer
- Sykdommer i det endokrine systemet
- Sukkersyke
- Diabetes mellitus, type 2
- Hypoglykemiske midler
- Fysiologiske effekter av legemidler
- Antineoplastiske midler
- Gastrointestinale midler
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Antineoplastiske midler, hormonelle
- Insulin
- Insulin, Globin sink
- Glukagon
- Oktreotid
Andre studie-ID-numre
- 0893-002
- 2005-002198-57 (EudraCT-nummer)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Type 2 diabetes mellitus
-
Instituto Nacional de Ciencias Medicas y Nutricion...Aktiv, ikke rekrutterende
-
Bangladesh Medical UniversityPåmelding etter invitasjon
-
University Hospital Inselspital, BerneFullført
-
India Diabetes Research Foundation & Dr. A. Ramachandran...Fullført
-
Dokuz Eylul UniversityAktiv, ikke rekrutterendeType 2 diabetes mellitus (T2DM) | Pasientaktivering | Diabetes Selvbehandling | Diabetes mellitus (DM)Tyrkia
-
El Katib HospitalHar ikke rekruttert ennåType 2 diabetes mellitus (T2DM)
-
He Eye HospitalHar ikke rekruttert ennå
-
Diabetes Solutions InternationalDexCom, Inc.; Tidepool; MAVEN ProjectRekrutteringType 2 diabetes mellitus (T2DM)Forente stater
-
Global Institute of Stem Cell Therapy and ResearchHar ikke rekruttert ennå
-
Daewoong Pharmaceutical Co. LTD.Har ikke rekruttert ennåT2DM (type 2 diabetes mellitus)
Kliniske studier på MK-0893 40 mg
-
Merck Sharp & Dohme LLCFullførtHypertensjon | Isolert systolisk hypertensjon (ISH)
-
Merck Sharp & Dohme LLCAvsluttetAlzheimers sykdom | Amnestisk mild kognitiv svikt | Prodromal Alzheimers sykdom
-
Merck Sharp & Dohme LLCFullførtPostoperativ kvalme og oppkast | Kjemoterapi-indusert kvalme og oppkast
-
Merck Sharp & Dohme LLCFullført
-
Genencell Co. Ltd.Rekruttering
-
Hanlim Pharm. Co., Ltd.FullførtFriske mannlige emnerKorea, Republikken
-
Merck Sharp & Dohme LLCFullført
-
Grupo Español de Tumores Huérfanos e InfrecuentesAstellas Pharma Inc; Apices Soluciones S.L.Fullført
-
Merck Sharp & Dohme LLCFullført
-
EMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyFullførtAvansert solid svulstForente stater