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 août 2015 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Type d'étude
Interventionnel
Inscription (Réel)
18
Phase
- La phase 1
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 50 ans (Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Homme
La description
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®.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
Autres noms:
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.
Autres noms:
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.
Autres noms:
|
|
Expérimental: 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.
Autres noms:
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.
Autres noms:
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.
Autres noms:
MK-0893 10 mg administered orally in 240 mL of water
|
|
Expérimental: 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.
Autres noms:
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.
Autres noms:
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.
Autres noms:
MK-0893 10 mg administered orally in 240 mL of water
|
|
Expérimental: 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.
Autres noms:
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.
Autres noms:
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.
Autres noms:
MK-0893 10 mg administered orally in 240 mL of water
|
|
Expérimental: 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.
Autres noms:
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.
Autres noms:
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.
Autres noms:
MK-0893 1000 mg administered orally in 240 mL of water
|
|
Expérimental: 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.
Autres noms:
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.
Autres noms:
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.
Autres noms:
MK-0893 1000 mg administered orally in 240 mL of water
|
|
Expérimental: 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.
Autres noms:
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.
Autres noms:
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.
Autres noms:
MK-0893 1000 mg administered orally in 240 mL of water
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Post-infusion Incremental Glucose Area Under the Plasma Concentration Versus Time Curve [AUC0-240 min] Study Part 1
Délai: 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
Délai: Up to 124 hours postdose
|
Up to 124 hours postdose
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Number of Participants With An Adverse Event (AE)
Délai: Up to 12 weeks
|
Up to 12 weeks
|
|
Number of Participants Who Discontinued Study Treatment Due To AEs
Délai: Up to 21 days of each treatment period
|
Up to 21 days of each treatment period
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 juillet 2005
Achèvement primaire (Réel)
1 décembre 2005
Achèvement de l'étude (Réel)
1 décembre 2005
Dates d'inscription aux études
Première soumission
3 décembre 2013
Première soumission répondant aux critères de contrôle qualité
10 décembre 2013
Première publication (Estimation)
16 décembre 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
19 août 2015
Dernière mise à jour soumise répondant aux critères de contrôle qualité
18 août 2015
Dernière vérification
1 août 2015
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Troubles du métabolisme du glucose
- Maladies métaboliques
- Maladies du système endocrinien
- Diabète sucré
- Diabète sucré, Type 2
- Agents hypoglycémiants
- Effets physiologiques des médicaments
- Agents antinéoplasiques
- Agents gastro-intestinaux
- Les hormones
- Hormones, substituts hormonaux et antagonistes hormonaux
- Agents antinéoplasiques, hormonaux
- Insuline
- Insuline, Globine Zinc
- Glucagon
- Octréotide
Autres numéros d'identification d'étude
- 0893-002
- 2005-002198-57 (Numéro EudraCT)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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