A Phase I, Double Blind, Placebo Controlled, First in Human, Single and Multiple Ascending Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Male and Female Subjects
NCT ID: NCT02639221
Last Updated: 2016-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
64 participants
INTERVENTIONAL
2016-01-31
2016-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Study Groups
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PXT002331
PXT002331
Placebo
PXT002331
Interventions
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PXT002331
Eligibility Criteria
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Inclusion Criteria
* permanently sterile following hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or confirmed tubal occlusion (not tubal ligation)
* postmenopausal, defined as at least 1 year post cessation of menses (without an alternative medical cause) 1.3. of any ethnic origin 1.4. between 18 and 60 years of age, inclusive
2. Subjects will have a 2.1. body mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2, inclusive 2.2. body weight between 50 kg and 100 kg, inclusive
3. Subjects will be in good health, as determined by; 3.1. medical history 3.2. physical examination 3.3. vital signs assessment 3.4. 12 lead ECG and 24 hour Holter Monitoring 3.5. clinical laboratory evaluations (congenital non haemolytic hyperbilirubinaemia is not acceptable)
4. Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions
18 Years
60 Years
ALL
Yes
Sponsors
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Prexton Therapeutics
INDUSTRY
Responsible Party
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Locations
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United Kingdom
United Kingdom, , United Kingdom
Countries
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Other Identifiers
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PXT-CL15-001
Identifier Type: -
Identifier Source: org_study_id
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