HealthyPhase 1UE2343NCT01770886
A Phase I Study of Oral UE2343 in Healthy Subjects
A Phase 1 study testing UE2343 in people with Healthy, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
A randomised, double-blind, placebo-controlled, phase I study in healthy subjects. Safety, pharmacokinetic and pharmacodynamic data will be collected. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- UE2343
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2013to Jul 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral UE2343 in Healthy Subjects
A randomised, double-blind, placebo-controlled, phase I study in healthy subjects. Safety, pharmacokinetic and pharmacodynamic data will be collected.
- Conditions
- Healthy
- Being tested
- UE2343, Placebo
- Keywords
- Drug Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UE2343Drug
Oral capsule
PlaceboDrug
Oral capsule
| Study group | Role | What they receive |
|---|---|---|
| UE2343 | Active comparator | Oral capsule Receives: Drug: UE2343 |
| Placebo | Placebo comparator | Oral capsule Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At each dose
Secondary outcomes (1)
Pharmacokinetic parameters of UE2343 and pharmacodynamic exposure
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
Measured: At each dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust, Simbec Research
- Responsible party
- Sponsor
- Investigators
- Brian R Walker, BSc MBChB MD, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01770886
- Sponsor's protocol ID
- UE2343
- Acronym
- UE2343
- Status last verified
- Jul 2013
- First submitted
- 10 Jan 2013
- Last updated
- 17 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral UE2343 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01770886
- Acronym / sponsor ID
- UE2343 / UE2343
- Conditions
- Healthy
- Keywords
- Drug Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- Wellcome Trust, Simbec Research
- Study start
- Jan 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 18 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomised, double-blind, placebo-controlled, phase I study in healthy subjects. Safety, pharmacokinetic and pharmacodynamic data will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UE2343 | Active comparator | Drug: UE2343Oral capsule |
| Placebo | Placebo comparator | Drug: PlaceboOral capsule |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UE2343Oral capsule | Drug | UE2343 |
| PlaceboOral capsule | Drug | Placebo |
Primary outcome
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
1 secondary outcome
Pharmacokinetic parameters of UE2343 and pharmacodynamic exposure
Time frame: At each dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian R Walker, BSc MBChB MD principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UE2343 in people with Healthy, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of UE2343 in healthy male/female subjects (time frame: At each dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2013.