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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

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ClinicalTrials.gov Identifier: NCT02639221
Recruitment Status : Completed
First Posted : December 24, 2015
Last Update Posted : September 28, 2016
Sponsor:
Information provided by (Responsible Party):
Prexton Therapeutics

Study Description
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Brief Summary:
The principal aim of this study is to obtain safety and tolerability data when PXT002331 is administered orally as single and multiple doses to healthy subjects.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: PXT002331 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: PXT002331 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
Study Start Date : January 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : September 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: PXT002331 Drug: PXT002331
Placebo Comparator: Placebo Drug: PXT002331


Outcome Measures
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Primary Outcome Measures :
  1. Number of Serious Adverse Events [ Time Frame: 16 days ]
  2. Number of clinically relevant signs or symptoms [ Time Frame: 16 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects will be; 1.1. males or females of non childbearing potential 1.2. For females, non childbearing potential is defined as follows:

    • 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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639221


Locations
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United Kingdom
United Kingdom
United Kingdom, United Kingdom
Sponsors and Collaborators
Prexton Therapeutics
More Information
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Responsible Party: Prexton Therapeutics
ClinicalTrials.gov Identifier: NCT02639221    
Other Study ID Numbers: PXT-CL15-001
First Posted: December 24, 2015    Key Record Dates
Last Update Posted: September 28, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases