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 augustus 2015 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Studietype
Ingrijpend
Inschrijving (Werkelijk)
18
Fase
- Fase 1
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 50 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Mannelijk
Beschrijving
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®.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
Andere namen:
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.
Andere namen:
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.
Andere namen:
|
|
Experimenteel: 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.
Andere namen:
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.
Andere namen:
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.
Andere namen:
MK-0893 10 mg administered orally in 240 mL of water
|
|
Experimenteel: 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.
Andere namen:
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.
Andere namen:
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.
Andere namen:
MK-0893 10 mg administered orally in 240 mL of water
|
|
Experimenteel: 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.
Andere namen:
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.
Andere namen:
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.
Andere namen:
MK-0893 10 mg administered orally in 240 mL of water
|
|
Experimenteel: 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.
Andere namen:
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.
Andere namen:
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.
Andere namen:
MK-0893 1000 mg administered orally in 240 mL of water
|
|
Experimenteel: 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.
Andere namen:
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.
Andere namen:
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.
Andere namen:
MK-0893 1000 mg administered orally in 240 mL of water
|
|
Experimenteel: 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.
Andere namen:
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.
Andere namen:
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.
Andere namen:
MK-0893 1000 mg administered orally in 240 mL of water
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Post-infusion Incremental Glucose Area Under the Plasma Concentration Versus Time Curve [AUC0-240 min] Study Part 1
Tijdsspanne: 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
Tijdsspanne: Up to 124 hours postdose
|
Up to 124 hours postdose
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Number of Participants With An Adverse Event (AE)
Tijdsspanne: Up to 12 weeks
|
Up to 12 weeks
|
|
Number of Participants Who Discontinued Study Treatment Due To AEs
Tijdsspanne: Up to 21 days of each treatment period
|
Up to 21 days of each treatment period
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 juli 2005
Primaire voltooiing (Werkelijk)
1 december 2005
Studie voltooiing (Werkelijk)
1 december 2005
Studieregistratiedata
Eerst ingediend
3 december 2013
Eerst ingediend dat voldeed aan de QC-criteria
10 december 2013
Eerst geplaatst (Schatting)
16 december 2013
Updates van studierecords
Laatste update geplaatst (Schatting)
19 augustus 2015
Laatste update ingediend die voldeed aan QC-criteria
18 augustus 2015
Laatst geverifieerd
1 augustus 2015
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Glucosemetabolismestoornissen
- Metabole ziekten
- Endocriene systeemziekten
- Suikerziekte
- Diabetes mellitus, type 2
- Hypoglycemische middelen
- Fysiologische effecten van medicijnen
- Antineoplastische middelen
- Gastro-intestinale middelen
- Hormonen
- Hormonen, hormoonvervangers en hormoonantagonisten
- Antineoplastische middelen, hormonaal
- Insuline
- Insuline, Globin Zink
- Glucagon
- Octreotide
Andere studie-ID-nummers
- 0893-002
- 2005-002198-57 (EudraCT-nummer)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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