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

• Register: ClinicalTrials.gov
• Last refreshed on: 10 October 2016
• Main ID: NCT02639221
• Date of registration: 17/12/2015
• Prospective Registration: Yes
• Primary sponsor: Prexton Therapeutics
• Public title: 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
• Scientific 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
• Date of first enrolment: January 2016
• Target sample size: 64
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02639221
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
• Phase: Phase 1

Countries of recruitment

United Kingdom

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: PXT002331

Primary Outcome(s)

Number of Serious Adverse Events [Time Frame: 16 days]

Number of clinically relevant signs or symptoms [Time Frame: 16 days]

Secondary ID(s)

PXT-CL15-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors