Multiple Ascending Dose Tolerability, Pharmacokinetic and Pharmacodynamic Study of DG3173

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: DG3173; Drug: Octreotide; Drug: DG3173 Placebo; Drug: DG3173+Octreotide; Drug: DG3173 Placebo+Octreotide Placebo; Drug: Octreotide+DG3173 Placebo

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DG3173	Drug: DG3173; Drug: Octreotide; Drug: DG3173 Placebo
Experimental: DG3173+Octreotide	Drug: DG3173+Octreotide; Drug: DG3173 Placebo+Octreotide Placebo; Drug: Octreotide+DG3173 Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Aspireo Pharmaceuticals Limited

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: August 14, 2014
• First Submitted That Met QC Criteria: August 14, 2014
• First Posted (Estimate): August 15, 2014

Study Record Updates

• Last Update Posted (Estimate): August 15, 2014
• Last Update Submitted That Met QC Criteria: August 14, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antineoplastic Agents; Gastrointestinal Agents; Antineoplastic Agents, Hormonal; Octreotide
• Other Study ID Numbers: DG3173-I-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No