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

Arm | Intervention/treatment |
---|---|
Experimental: PXT002331 |
Drug: PXT002331 |
Placebo Comparator: Placebo |
Drug: PXT002331 |
- Number of Serious Adverse Events [ Time Frame: 16 days ]
- Number of clinically relevant signs or symptoms [ Time Frame: 16 days ]

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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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
- 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
- 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)
- Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions

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
United Kingdom | |
United Kingdom | |
United Kingdom, United Kingdom |
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 |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |