Multiple Ascending Dose Tolerability, Pharmacokinetic and Pharmacodynamic Study of DG3173

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: DG3173; Drug: DG3173+Octreotide; Drug: Octreotide; Drug: DG3173 Placebo+Octreotide Placebo; Drug: DG3173 Placebo; Drug: Octreotide+DG3173 Placebo

• Registration Number: NCT02217839
• Lead Sponsor: Aspireo Pharmaceuticals Limited

Brief Summary

This multi-ascending dose study is designed to investigate the safety, tolerability, pharmacokinetic and side effect profile of multiple ascending doses of DG3173, in up to 48 healthy volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2013-01
• Status Verified: 2014-08
• Study First Submitted: 2014-08-14
• Study First Submitted QC: 2014-08-14
• Last Update Submitted: 2014-08-14
• Study First Posted: 2014-08-15
• Last Update Posted: 2014-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 42

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

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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 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DG3173	DG3173 Placebo	-
DG3173+Octreotide	Octreotide+DG3173 Placebo	-
DG3173	DG3173	-
DG3173	Octreotide	-
DG3173+Octreotide	DG3173+Octreotide	-
DG3173+Octreotide	DG3173 Placebo+Octreotide Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of serious adverse events or withdrawals due to adverse events. Laboratory investigations (including biochemistry, hematology, and urinalysis), vital signs (blood pressure, pulse rate), and 12-lead ECG.	10 days