A Phase I Study of Oral UE2343 in Healthy Subjects

NCT01770886 | Completed Phase 1

• 1 other identifier: UE2343
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Drug Safety

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of UE2343 in healthy male/female subjects

  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

  At each dose

Secondary Outcomes (1)

• Pharmacokinetic parameters of UE2343 and pharmacodynamic exposure

  At each dose

Study Arms (2)

UE2343

ACTIVE COMPARATOR

Oral capsule

Drug: UE2343

Placebo

PLACEBO COMPARATOR

Oral capsule

Drug: Placebo

Interventions

UE2343 DRUG

Oral capsule

UE2343

Placebo DRUG

Oral capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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/m2. Body Mass Index = Body weight (kg) / \[Height (m)\]2.
• 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 2. The Simbec normal ranges are shown in Appendix 3.
• 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.
• Subject with no clinically significant abnormalities in 12-lead electrocardiogram (ECG).
• no clinically significant abnormalities in vital signs.
• willing and able to comply with the requirements of the protocol.
• satisfy a medical examiner about fitness to participate in the study.
• provide written informed consent to participate in the study.
• Smokers are eligible to participate in the study.

You may not qualify if:

• 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 UE2343.
• 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).

Sponsors & Collaborators

• University of Edinburgh: lead
• Wellcome Trust: collaborator
• Simbec Research: collaborator

Study Sites (1)

Simbec Research

Merthyr Tydfil, CF48 4DR, United Kingdom

Location

MeSH Terms

Interventions

UE2343

Study Officials

• Brian R Walker, BSc MBChB MD

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2013
• First Posted: January 18, 2013
• Study Start: January 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 17, 2013

Record last verified: 2013-07

Locations

GB (1)