Trial | NCT02639221  Report issue

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
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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    64
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.
Study Started
Jan 31
2016
Primary Completion
Aug 31
2016
Study Completion
Sep 30
2016
Last Update
Sep 28
2016
Estimate

Drug PXT002331

PXT002331 Experimental

Placebo Placebo Comparator

Criteria 

Inclusion Criteria:

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
No Results Posted