NCT02521389

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 29, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 4, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2017

Completed
Last Updated

August 29, 2017

Status Verified

August 1, 2017

Enrollment Period

1.7 years

First QC Date

August 4, 2015

Last Update Submit

August 28, 2017

Conditions

Malignancies

Outcome Measures

Primary Outcomes (1)

  • The number of participants with and types of Adverse Events

    5 months

Secondary Outcomes (3)

  • Tmax (time from dosing at which Cmax is determined)

    5 months

  • Cmax (maximum observed plasma concentration)

    5 months

  • AUC (area under the concentration time curve)

    5 months

Study Arms (2)

Part 1

EXPERIMENTAL

3 sequential groups (Groups A, B and C), comprising 3, 6 and 6 subjects, respectively, with 2 optional additional groups (Groups D and E), each comprising 6 subjects, to assess alternative dose levels or formulations (described below), if required.

Drug: PWT-143

Part 2

EXPERIMENTAL

Single dose, 2-way crossover design to assess a selected formulation of PWT-143 in the fed and fasted states in 8 subjects.

Drug: PWT-143

Interventions

PWT-143DRUG

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

Part 1Part 2

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy males
  • Age 18 to 65 years of age
  • Body mass index of 18.0 to 32.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
  • Part 2 only: Must be able to consume all food items in a standard high fat breakfast and/or have no conditions or surgery (eg, cholecystectomy) that could affect their ability to eat the high fat breakfast
  • Must be willing and able to communicate and participate in the whole study
  • Must be willing to provide voluntary written informed consent before performance of any study-related procedure that is not part of normal medical care
  • Must agree to use an adequate method of contraception

You may not qualify if:

  • Healthy males
  • Age 18 to 65 years of age
  • Body mass index of 18.0 to 32.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
  • Part 2 only: Must be able to consume all food items in a standard high fat breakfast and/or have no conditions or surgery (eg, cholecystectomy) that could affect their ability to eat the high fat breakfast
  • Must be willing and able to communicate and participate in the whole study
  • Must be willing to provide voluntary written informed consent before performance of any study-related procedure that is not part of normal medical care
  • Must agree to use an adequate method of contraception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quotient Clinical

Ruddington, Nottingham, NG11 6JS, United Kingdom

Location

Related Publications (1)

  • Moreno O, Butler T, Zann V, Willson A, Leung P, Connor A. Safety, Pharmacokinetics, and Pharmacodynamics of ME-401, an Oral, Potent, and Selective Inhibitor of Phosphatidylinositol 3-Kinase P110delta, Following Single Ascending Dose Administration to Healthy Volunteers. Clin Ther. 2018 Nov;40(11):1855-1867. doi: 10.1016/j.clinthera.2018.09.006. Epub 2018 Oct 26.

    PMID: 30458930DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Pui Leung, MBChB

    Study Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2015

First Posted

August 13, 2015

Study Start

June 29, 2015

Primary Completion

February 24, 2017

Study Completion

February 24, 2017

Last Updated

August 29, 2017

Record last verified: 2017-08

Locations

GB(1)