Multiple Ascending Dose Tolerability, Pharmacokinetic and Pharmacodynamic Study of DG3173

NCT02217839 | Completed Phase 1

• 1 other identifier: DG3173-I-002
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

DG3173

EXPERIMENTAL

Drug: DG3173; Drug: Octreotide; Drug: DG3173 Placebo

DG3173+Octreotide

EXPERIMENTAL

Drug: DG3173+Octreotide; Drug: DG3173 Placebo+Octreotide Placebo; Drug: Octreotide+DG3173 Placebo

Interventions

DG3173 DRUG

DG3173

DG3173+Octreotide DRUG

DG3173+Octreotide

Octreotide DRUG

DG3173

DG3173 Placebo DRUG

DG3173

DG3173 Placebo+Octreotide Placebo DRUG

DG3173+Octreotide

Octreotide+DG3173 Placebo DRUG

DG3173+Octreotide

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aspireo Pharmaceuticals Limited: lead

MeSH Terms

Interventions

PTR 3173; Octreotide

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2014
• First Posted: August 15, 2014
• Study Start: April 1, 2012
• Primary Completion: January 1, 2013
• Last Updated: August 15, 2014

Record last verified: 2014-08