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

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02639221
• Other study ID #: PXT-CL15-001
• Status: Completed
• Phase: Phase 1
• First received: December 17, 2015
• Last updated: September 27, 2016
• Start date: January 2016
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Prexton Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom : The Medicines and Health products Regulatory Agency (MHRA)United Kingdom : North West - Greater Manchester Central Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• PXT002331

Locations

Country	Name	City	State
United Kingdom	United Kingdom	United Kingdom

Sponsors (1)

Lead Sponsor	Collaborator
Prexton Therapeutics

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Serious Adverse Events		16 days	Yes
Primary	Number of clinically relevant signs or symptoms		16 days	Yes