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

Phase 1

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: PXT002331

• Registration Number: NCT02639221
• Lead Sponsor: Prexton Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-17
• Study First Submitted QC: 2015-12-20
• Study First Posted: 2015-12-24
• Study Start: 2016-01
• Primary Completion: 2016-08
• Status Verified: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-09-27
• Last Update Posted: 2016-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PXT002331	PXT002331	-
Placebo	PXT002331	-

Primary Outcome Measures

Name	Time	Method
Number of Serious Adverse Events	16 days
Number of clinically relevant signs or symptoms	16 days

Trial Locations

Locations (1)

United Kingdom; 🇬🇧 United Kingdom, United Kingdom