Single Dose Pharmacodynamic and Pharmacokinetic Study of DG3173

Study Overview
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Brief Summary
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In this single-dose, randomized, 5-way cross-over study, healthy volunteers were treated with the highest approved dose of octreotide, three different doses of Somatoprim (DG3173) and placebo control. The main purpose of the study was to investigate the effects of each treatment on the control of plasma glucose as well as the secretion of insulin and glucagon following a standard meal.

Conditions
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Healthy

Intervention / Treatment
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* Drug: DG3173
* Drug: Saline
* Drug: Octreotide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ethnic origin: Caucasian Body Mass Index (BMI): 19-27 kg/m2 inclusive Medical history without clinically relevant pathologies Physical examination parameters without signs of clinically relevant pathologies Electrocardiogram recording without signs of clinically relevant pathology, in particular QTc (Bazett) <450 ms Values for hematology and for biochemistry tests of blood and urine within the normal range or showing no clinically relevant deviation as judged by the Investigator (in particular for alanine transaminase, aspartate transaminase, lactate dehydrogenase, gamma glutamyl transferase, alkaline phosphatase, bilirubin, and α-amylase) Subjects with partner of child bearing potential must be willing to practice a medically approved method of contraception (e.g., condom in combination with hormonal contraception or intrauterine device or a diaphragm with spermicide after the first drug administration and for one month after participation in the study or are vasectomized since > 6 months or has a partner being sterilized since > 6 months Having given written informed consent before any study-related activities are carried out Exclusion Criteria: Evidence of clinically relevant pathology or disease Any history of moderate or severe hypertension, hypotension or orthostatic hypotension Mental handicap Legal incapacity Any history of clinically important emotional and/or psychiatric illness or of any clinically important neurological disorders and/or epilepsy Chronic diarrhea or other acute or chronic gastrointestinal disorders Presence or history of endocrine disorders Presence or history of gallstone disease Known hypersensitivity to the study drug or constituent of the study drug History of any relevant allergy, especially drug and/or food allergies Strict vegetarian Regular treatment with medications during three months prior to randomization Receipt of any prescription or non-prescription medication, including multi vitamin preparations within 14 days prior randomization and for the duration of the study Use of St. John's Wort or Ginkgo Biloba (also known as Ginkgo Bilbao) within 48 hours prior to randomization Participation in a clinical study within 30 days prior to randomization Donation of blood (450 ml) within 60 days prior to randomization Receipt of blood, blood products or plasma derivates one year prior to randomization Regular smoking of >5 cigarettes per day within the past three months Any history of alcohol abuse or drug addiction Known consumer of drugs of abuse Known to be infected with HBsAg, anti-HCV, or anti-HIV1 and HIV2 Consumption of abnormal quantities of coffee or tea (i.e., more than 5 cups per day [1 cup = 150 ml]) Any disease which in the Investigator's opinion would exclude the subject from the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DG3173<br> | Drug: DG3173<br> <br> Drug: Saline<br> <br> Drug: Octreotide<br> <br> |
| Placebo Comparator: Saline<br> | Drug: DG3173<br> <br> Drug: Saline<br> <br> Drug: Octreotide<br> <br> |
| Active Comparator: Octreotide<br> | Drug: DG3173<br> <br> Drug: Saline<br> <br> Drug: Octreotide<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of glucose, insulin and glucagon in plasma. |  | Before and 0.5h, 0.75h, 1h, 1.25 h, 1.5h, 1.75h, 2.25h, 2.75, 3.25h, 3.75h and 4.25h after drug adaministration until 4.25 hours after administration |