Multiple Ascending Dose Tolerability, Pharmacokinetic and Pharmacodynamic Study of DG3173

Aspireo Pharmaceuticals Limited0 sites42 target enrollmentApril 2012

InterventionsDG3173 Octreotide DG3173 Placebo DG3173+Octreotide DG3173 Placebo+Octreotide Placebo Octreotide+DG3173 Placebo

DrugsDG3173 DG3173+Octreotide Octreotide DG3173 Placebo DG3173 Placebo+Octreotide Placebo Octreotide+DG3173 Placebo

Overview

Phase: Phase 1
Intervention: DG3173
Conditions: Healthy
Sponsor: Aspireo Pharmaceuticals Limited
Enrollment: 42
Primary Endpoint: 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.
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2012

End Date

January 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Aspireo Pharmaceuticals Limited

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

DG3173

Intervention: DG3173

DG3173

Intervention: Octreotide

DG3173

Intervention: DG3173 Placebo

DG3173+Octreotide

Intervention: DG3173+Octreotide

DG3173+Octreotide

Intervention: DG3173 Placebo+Octreotide Placebo

DG3173+Octreotide

Intervention: Octreotide+DG3173 Placebo

Outcomes

Primary Outcomes

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.

Time Frame: 10 days