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)
Status and phase
Completed
Phase 1
Conditions
Type 2 Diabetes Mellitus
Treatments
Drug: MK-0893 1000 mg
Drug: MK-0893 10 mg
Biological: Glucagon
Drug: MK-0893 200 mg
Drug: Placebo
Biological: Sandostatine®
Drug: MK-0893 40 mg
Biological: Insulin
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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.
Enrollment
18 patients
Sex
Male
Ages
18 to 50 years old
Volunteers
Accepts Healthy Volunteers
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®.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Double Blind
18 participants in 7 patient groups
MK-0893 40 mg→MK-0893 200 mg→placebo
Experimental group
Description:
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.
Treatment:
Biological: Insulin
Drug: MK-0893 40 mg
Biological: Sandostatine®
Biological: Glucagon
Drug: MK-0893 200 mg
Drug: Placebo
MK-0893 200 mg→placebo→MK-0893 10 mg
Experimental group
Description:
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.
Treatment:
Biological: Insulin
Drug: MK-0893 10 mg
Biological: Sandostatine®
Biological: Glucagon
Drug: MK-0893 200 mg
Drug: Placebo
Placebo→MK-0893 10 mg→MK-0893 40 mg
Experimental group
Description:
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.
Treatment:
Biological: Insulin
Drug: MK-0893 10 mg
Drug: MK-0893 40 mg
Biological: Sandostatine®
Biological: Glucagon
Drug: Placebo
MK-0893 10 mg→MK-0893 40 mg→MK-0893 200 mg
Experimental group
Description:
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.
Treatment:
Biological: Insulin
Drug: MK-0893 10 mg
Drug: MK-0893 40 mg
Biological: Sandostatine®
Biological: Glucagon
Drug: MK-0893 200 mg
Placebo→MK-0893 1000 mg→MK-0893 200 mg
Experimental group
Description:
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.
Treatment:
Biological: Insulin
Drug: MK-0893 1000 mg
Biological: Sandostatine®
Biological: Glucagon
Drug: MK-0893 200 mg
Drug: Placebo
MK-0893 200 mg→placebo→MK-0893 1000 mg
Experimental group
Description:
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.
Treatment:
Biological: Insulin
Drug: MK-0893 1000 mg
Biological: Sandostatine®
Biological: Glucagon
Drug: MK-0893 200 mg
Drug: Placebo
MK-0893 1000 mg→MK-0893 200 mg→placebo
Experimental group
Description:
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.
Treatment:
Biological: Insulin
Drug: MK-0893 1000 mg
Biological: Sandostatine®
Biological: Glucagon
Drug: MK-0893 200 mg
Drug: Placebo
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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