- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02012166
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)
August 18, 2015 updated by: 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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
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®.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
Other Names:
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.
Other Names:
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.
Other Names:
|
Experimental: 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.
Other Names:
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.
Other Names:
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.
Other Names:
MK-0893 10 mg administered orally in 240 mL of water
|
Experimental: 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.
Other Names:
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.
Other Names:
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.
Other Names:
MK-0893 10 mg administered orally in 240 mL of water
|
Experimental: 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.
Other Names:
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.
Other Names:
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.
Other Names:
MK-0893 10 mg administered orally in 240 mL of water
|
Experimental: 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.
Other Names:
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.
Other Names:
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.
Other Names:
MK-0893 1000 mg administered orally in 240 mL of water
|
Experimental: 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.
Other Names:
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.
Other Names:
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.
Other Names:
MK-0893 1000 mg administered orally in 240 mL of water
|
Experimental: 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.
Other Names:
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.
Other Names:
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.
Other Names:
MK-0893 1000 mg administered orally in 240 mL of water
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Post-infusion Incremental Glucose Area Under the Plasma Concentration Versus Time Curve [AUC0-240 min] Study Part 1
Time Frame: 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
Time Frame: Up to 124 hours postdose
|
Up to 124 hours postdose
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants With An Adverse Event (AE)
Time Frame: Up to 12 weeks
|
Up to 12 weeks
|
Number of Participants Who Discontinued Study Treatment Due To AEs
Time Frame: Up to 21 days of each treatment period
|
Up to 21 days of each treatment period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2005
Primary Completion (Actual)
December 1, 2005
Study Completion (Actual)
December 1, 2005
Study Registration Dates
First Submitted
December 3, 2013
First Submitted That Met QC Criteria
December 10, 2013
First Posted (Estimate)
December 16, 2013
Study Record Updates
Last Update Posted (Estimate)
August 19, 2015
Last Update Submitted That Met QC Criteria
August 18, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Antineoplastic Agents
- Gastrointestinal Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Insulin
- Insulin, Globin Zinc
- Glucagon
- Octreotide
Other Study ID Numbers
- 0893-002
- 2005-002198-57 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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