A Phase I Study of Oral UE2343 in Healthy Subjects

This study has been completed.
Sponsor:
Collaborators:
Wellcome Trust
Simbec Research
Information provided by (Responsible Party):
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT01770886
First received: January 10, 2013
Last updated: July 16, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention Phase
Healthy
Drug: UE2343
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral UE2343 in Healthy Subjects

Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • Safety and tolerability of UE2343 in healthy male/female subjects [ Time Frame: At each dose ] [ Designated as safety issue: Yes ]

    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


Secondary Outcome Measures:
  • Pharmacokinetic parameters of UE2343 and pharmacodynamic exposure [ Time Frame: At each dose ] [ Designated as safety issue: No ]

    Days 1-2 at each dose:

    • Blood and urine samples for measurement of UE2343
    • Blood samples for adrenal androgens
    • Blood samples for ACTH and cortisol
    • Urine samples for urinary free steroids

    Days 3-6 at each dose:

    • Blood and urine samples for measurement of UE2343
    • Blood samples for adrenal androgens
    • Blood samples for ACTH and cortisol
    • Urine samples for urinary free steroids


Enrollment: 48
Study Start Date: January 2013
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: UE2343
Oral capsule
Drug: UE2343
Oral capsule
Placebo Comparator: Placebo
Oral capsule
Drug: Placebo
Oral capsule

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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/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.

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 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).
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01770886

Locations
United Kingdom
Simbec Research
Merthyr Tydfil, United Kingdom, CF48 4DR
Sponsors and Collaborators
University of Edinburgh
Wellcome Trust
Simbec Research
Investigators
Principal Investigator: Brian R Walker, BSc MBChB MD University of Edinburgh
  More Information

No publications provided

Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT01770886     History of Changes
Other Study ID Numbers: UE2343
Study First Received: January 10, 2013
Last Updated: July 16, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Edinburgh:
Drug Safety

ClinicalTrials.gov processed this record on July 22, 2014