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Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Various Formulations and Doses of PWT-143

NCT02521389 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2017-08-29

No results posted yet for this study

Summary

This single center first in human (FIH) study will comprise 2 parts; Part 1 will consist of 3 sequential dose groups (Groups A, B and C) and Part 2 will consist of 1 dose group (Group A). There will be an option to include 2 additional dose groups in Part 1 (Groups D and E) to assess alternative dose levels or formulations, if required.

In each study part, each subject will receive a single dose of investigational medicinal product PWT-143 in each of 2 study periods (total of 2 single doses).

Conditions

Interventions

DRUG

PWT-143

phosphatidylinositol-4,5-bisphosphate 3-kinase (PI3K) delta inhibitor

Sponsors & Collaborators

  • Quotient Clinical

    collaborator OTHER

  • MEI Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Pui Leung, MBChB · Study Principal Investigator

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-29
Primary Completion
2017-02-24
Completion
2017-02-24

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02521389 on ClinicalTrials.gov