NCT04688580

Brief Summary

The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of various formulations of XW10172 in healthy volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P50-P75 for early_phase_1 healthy

Timeline
Completed

Started Nov 2020

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

First Submitted

Initial submission to the registry

November 14, 2020

Completed
15 days until next milestone

Study Start

First participant enrolled

November 29, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 30, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2021

Completed
Last Updated

November 4, 2022

Status Verified

November 1, 2022

Enrollment Period

1 year

First QC Date

November 14, 2020

Last Update Submit

November 2, 2022

Conditions

Healthy

Outcome Measures

Primary Outcomes (9)

  • Maximum concentration (Cmax)

    12 hours

  • Trough concentration (Cmin)

    12 hours

  • Area under the concentration-time curve (AUC) from 0 to time of last quantifiable concentration (AUC0-tlast)

    12 hours

  • AUC from time 0 extrapolated to infinity (AUC0-inf)

    12 hours

  • AUC over the dosing interval (AUCtau)

    12 hours

  • Apparent terminal half-life (t1/2)

    12 hours

  • Cmax and AUC ratios of metabolite to XW10172

    12 hours

  • Apparent oral clearance (CL/F)

    12 hours

  • Time to reach Cmax (Tmax)

    12 hours

Secondary Outcomes (1)

  • Incidence, severity, and causality of AEs

    Up to 14 Days

Study Arms (1)

XW10172

EXPERIMENTAL
Drug: XW10172

Interventions

XW10172DRUG

Various formulations

XW10172

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male of female participants who are 18 to 55 years of age, inclusive.
  • Participant is willing and able to provide signed and dated written informed consent to participate prior to admission to the study.

You may not qualify if:

  • Evidence or history of clinically significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, psychiatric, neurological, immunological, or endocrine disorders, poor vision, or allergic disease including drug allergies, including immediate type hypersensitivity. A history of childhood asthma that has resolved is acceptable.
  • Participant who, for any reason, is deemed by the investigator to be inappropriate for this study; or has any condition which would confound or interfere with the evaluation of the safety, tolerability, pharmacokinetics or pharmacodynamics of the investigational drug; or is unable to comply with the study protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CMAX

Adelaide, South Australia, 5000, Australia

Location

Study Officials

  • Daniel M. Canafax, PharmD

    XWPharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2020

First Posted

December 30, 2020

Study Start

November 29, 2020

Primary Completion

December 14, 2021

Study Completion

December 14, 2021

Last Updated

November 4, 2022

Record last verified: 2022-11

Locations

AU(1)