A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral UE2343 in Healthy Subjects

University of Edinburgh1 site in 1 country48 target enrollmentJanuary 2013

ConditionsHealthy

InterventionsUE2343 Placebo

DrugsUE2343 Placebo

Overview

Phase: Phase 1
Intervention: UE2343
Conditions: Healthy
Sponsor: University of Edinburgh
Enrollment: 48
Locations: 1
Primary Endpoint: Safety and tolerability of UE2343 in healthy male/female subjects
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A randomised, double-blind, placebo-controlled, phase I study in healthy subjects. Safety, pharmacokinetic and pharmacodynamic data will be collected.

Registry

clinicaltrials.gov

Start Date

January 2013

End Date

July 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Edinburgh

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy male and female subjects between 18 and 65 years of age (inclusive).
•Female subject is postmenopausal or surgically sterilized or had a hysterectomy.
•Female subject with negative pregnancy test.
•Male subjects willing to use an effective method of contraception, if applicable (unless anatomically sterile or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the subject) from Day 1 until 3 months afterwards.
•Subject with a Body Mass Index (BMI) of 18-30 kg/m
•Body Mass Index = Body weight (kg) / \[Height (m)\]
•Subject with no clinically significant abnormal serum biochemistry, haematology and urine examination values or results suggesting an infectious or other systemic disorder. The parameters to be measured will include those shown in Appendix
•The Simbec normal ranges are shown in Appendix
•Subject with a negative urinary drugs of abuse screen (Appendix 2) (N.B. a positive alcohol result may be repeated at the discretion of the Investigator).
•Subject with negative HIV and Hepatitis B and C results.

Exclusion Criteria

•Relevant abnormality in medical history or on examination, including history of dementia, or other psychiatric, neurological, immunological, respiratory or cardiovascular disorder. Particularly exclude subjects with signs of peripheral neuropathy. Abnormal laboratory findings suggesting the presence of a systematic disorder.
•Participation in a clinical study of an unlicensed drug in the previous 4 months, or a marketed drug study within the previous 3 months. (N.B. washout period between trials defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study).
•Known allergies, including allergy to chemicals like and excipients associated with UE
•Recent or clinically significant history of drug or alcohol abuse.
•Blood donation greater than 500 ml in the previous 3 months.
•Inability to communicate well with the Investigator (i.e., language problem, poor mental development or impaired cerebral function).
•Receipt of regular prescribed medication within 7 days of the first study day and / or receipt of vitamins, minerals, herbal remedies and nutritional supplements within 7 days of the first study day. Subjects taking long lasting drugs more than 7 days before the study may be excluded at the physician's discretion. Inclusion of subjects who have taken over the counter drugs during this period will be reviewed on a case-by-case basis in relation to the safety aspects and objectives of this study.

Arms & Interventions

UE2343

Oral capsule

Intervention: UE2343

Placebo

Oral capsule

Intervention: Placebo

Outcomes

Primary Outcomes

Safety and tolerability of UE2343 in healthy male/female subjects

Time Frame: At each dose

Days 1-2 at each dose: * 12 lead ECG * Vital signs * Symptom led clinical assessment (day 1 only) * Routine laboratory assessments Days 3-6 at each dose: * 12 lead ECG * Vital signs * Routine laboratory assessments Day 10 at each dose: * 12 lead ECG * Vital signs * Routine laboratory assessments * Physical examination * Pregnancy test