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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04688580




Registration number
NCT04688580
Ethics application status
Date submitted
14/11/2020
Date registered
30/12/2020
Date last updated
4/11/2022

Titles & IDs
Public title
Pharmacokinetics, Safety, and Tolerability of Various XW10172 Oral Formulations in Healthy Adult Volunteers
Scientific title
An Open-label, Crossover Study to Assess the Pharmacokinetics, Safety, and Tolerability of Various XW10172 Oral Immediate- and Modified-release Formulations in Healthy Adult Volunteers
Secondary ID [1] 0 0
XW10172-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - XW10172

Experimental: XW10172 -


Treatment: Drugs: XW10172
Various formulations
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum concentration (Cmax)
Timepoint [1] 0 0
12 hours
Primary outcome [2] 0 0
Trough concentration (Cmin)
Timepoint [2] 0 0
12 hours
Primary outcome [3] 0 0
Area under the concentration-time curve (AUC) from 0 to time of last quantifiable concentration (AUC0-tlast)
Timepoint [3] 0 0
12 hours
Primary outcome [4] 0 0
AUC from time 0 extrapolated to infinity (AUC0-inf)
Timepoint [4] 0 0
12 hours
Primary outcome [5] 0 0
AUC over the dosing interval (AUCtau)
Timepoint [5] 0 0
12 hours
Primary outcome [6] 0 0
Apparent terminal half-life (t1/2)
Timepoint [6] 0 0
12 hours
Primary outcome [7] 0 0
Cmax and AUC ratios of metabolite to XW10172
Timepoint [7] 0 0
12 hours
Primary outcome [8] 0 0
Apparent oral clearance (CL/F)
Timepoint [8] 0 0
12 hours
Primary outcome [9] 0 0
Time to reach Cmax (Tmax)
Timepoint [9] 0 0
12 hours
Secondary outcome [1] 0 0
Incidence, severity, and causality of AEs
Timepoint [1] 0 0
Up to 14 Days

Eligibility
Key inclusion criteria
- 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- 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.

Study design
Purpose of the study
Other
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 0
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/12/2021
Sample size
Target
Accrual to date
Final
46
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
XWPharma
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of
various formulations of XW10172 in healthy volunteers.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04688580
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Daniel M. Canafax, PharmD
Address 0 0
XWPharma
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04688580