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Clinical Trials/EUCTR2011-003808-20-DE
EUCTR2011-003808-20-DE
Active, not recruiting
Not Applicable

A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EV-077-3201-2TBS in Healthy Subjects and Type 2 Diabetic Subjects

Evolva SA0 sites96 target enrollmentAugust 22, 2011
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ConditionsHealthy subjects and subjects with Type 2 DiabetesMedDRA version: 14.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
DrugsAspirin N 100mg

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy subjects and subjects with Type 2 Diabetes
Sponsor
Evolva SA
Enrollment
96
Status
Active, not recruiting
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 22, 2011
End Date
TBD
Last Updated
12 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Evolva SA

Eligibility Criteria

Inclusion Criteria

  • •All Parts (A, B and C)
  • •1\.Informed consent obtained before any trial\-related activities.
  • •2\.A male with a partner of childbearing potential must only be allowed to participate if:
  • •he and his partner are willing to use a medically acceptable method of birth control (e.g. condom in combination with hormonal contraception or intrauterine device, or a diaphragm with spermicide) during the study and for 3 months after participation in the study, or
  • •he is vasectomized (\> 6 months), or
  • •he has a sterilized partner (\> 6 months), or
  • •he is abstinent during the study and for 3 months after participation in the study.
  • •Parts A and B only
  • •3\.Healthy male subjects aged 18 to 50 inclusive.
  • •4\.Body weight 70 to 90 kg inclusive.

Exclusion Criteria

  • •All Parts (A, B and C)
  • •1\.Employees or personnel affiliated with the Sponsor or Investigator.
  • •2\.Previous participation (randomisation) in this trial.
  • •3\.The intake of any investigational drug within one month or five half\-lives, whatever is longer, before administration of study drug.
  • •4\.A history of significant multiple drug allergies or with a known allergy to the trial product or any medicine chemically related to the trial product, as judged by the Investigator.
  • •5\.Clinically significant acute illness within 2 weeks before administration of study drug, including severe infections, as judged by the Investigator.
  • •6\.Abnormal and clinically significant ECG at screening.
  • •7\.Donation of any blood or plasma in the past month or in excess of 500 mL within the 12 weeks preceding screening.
  • •8\.Intake of paracetamol within 7 days before start of treatment.
  • •9\.Surgery or trauma with significant blood loss within the last 3 months before administration of study drug.

Outcomes

Primary Outcomes

Not specified

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