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)
tiistai 18. elokuuta 2015 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Valmis
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
18
Vaihe
- Vaihe 1
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta - 50 vuotta (Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Joo
Sukupuolet, jotka voivat opiskella
Uros
Kuvaus
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®.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Crossover-tehtävä
- Naamiointi: Kaksinkertainen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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.
Muut nimet:
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.
Muut nimet:
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.
Muut nimet:
|
|
Kokeellinen: 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.
Muut nimet:
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.
Muut nimet:
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.
Muut nimet:
MK-0893 10 mg administered orally in 240 mL of water
|
|
Kokeellinen: 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.
Muut nimet:
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.
Muut nimet:
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.
Muut nimet:
MK-0893 10 mg administered orally in 240 mL of water
|
|
Kokeellinen: 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.
Muut nimet:
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.
Muut nimet:
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.
Muut nimet:
MK-0893 10 mg administered orally in 240 mL of water
|
|
Kokeellinen: 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.
Muut nimet:
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.
Muut nimet:
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.
Muut nimet:
MK-0893 1000 mg administered orally in 240 mL of water
|
|
Kokeellinen: 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.
Muut nimet:
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.
Muut nimet:
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.
Muut nimet:
MK-0893 1000 mg administered orally in 240 mL of water
|
|
Kokeellinen: 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.
Muut nimet:
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.
Muut nimet:
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.
Muut nimet:
MK-0893 1000 mg administered orally in 240 mL of water
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
|
Post-infusion Incremental Glucose Area Under the Plasma Concentration Versus Time Curve [AUC0-240 min] Study Part 1
Aikaikkuna: 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
Aikaikkuna: Up to 124 hours postdose
|
Up to 124 hours postdose
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
|
Number of Participants With An Adverse Event (AE)
Aikaikkuna: Up to 12 weeks
|
Up to 12 weeks
|
|
Number of Participants Who Discontinued Study Treatment Due To AEs
Aikaikkuna: Up to 21 days of each treatment period
|
Up to 21 days of each treatment period
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Perjantai 1. heinäkuuta 2005
Ensisijainen valmistuminen (Todellinen)
Torstai 1. joulukuuta 2005
Opintojen valmistuminen (Todellinen)
Torstai 1. joulukuuta 2005
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Tiistai 3. joulukuuta 2013
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Tiistai 10. joulukuuta 2013
Ensimmäinen Lähetetty (Arvio)
Maanantai 16. joulukuuta 2013
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Keskiviikko 19. elokuuta 2015
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Tiistai 18. elokuuta 2015
Viimeksi vahvistettu
Lauantai 1. elokuuta 2015
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Glukoosiaineenvaihduntahäiriöt
- Metaboliset sairaudet
- Endokriinisen järjestelmän sairaudet
- Diabetes mellitus
- Diabetes mellitus, tyyppi 2
- Hypoglykeemiset aineet
- Huumeiden fysiologiset vaikutukset
- Antineoplastiset aineet
- Ruoansulatuskanavan aineet
- Hormonit
- Hormonit, hormonikorvikkeet ja hormoniantagonistit
- Antineoplastiset aineet, hormonaaliset
- Insuliini
- Insuliini, Globiini Sinkki
- Glukagoni
- Oktreotidi
Muut tutkimustunnusnumerot
- 0893-002
- 2005-002198-57 (EudraCT-numero)
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .
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