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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/NCT04966832




Registration number
NCT04966832
Ethics application status
Date submitted
12/07/2021
Date registered
19/07/2021
Date last updated
4/11/2022

Titles & IDs
Public title
Safety, Tolerability and Pharmacokinetics of XW10508 Immediate and Modified Release Formulations in Healthy Adults
Scientific title
A Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics of XW10508 Immediate and Modified Release Formulations in Healthy Adults
Secondary ID [1] 0 0
XW10508-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - XW10508
Other interventions - Placebo

Experimental: XW10508 - XW10508 capsules or tablets

Placebo Comparator: Placebo - Placebo capsules or tablets


Treatment: Drugs: XW10508
XW10508 capsules or tablets

Other interventions: Placebo
Placebo capsules or tablets
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

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

Eligibility
Key inclusion criteria
- Healthy male or 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 (in the opinion of the investigator)
gastrointestinal, hepatic, renal, respiratory (e.g., asthma, COPD), cardiovascular
(e.g., hypertension), metabolic, psychiatric, neurological, immunological, or
endocrine disorders, or allergic disease including drug allergies, including immediate
type hypersensitivity to components of the study drug. A history of childhood asthma
that has resolved is acceptable.

- Use of tobacco- or nicotine-containing products (e.g., cigarettes, cigars, chewing
tobacco, snuff, patches, vaping device, etc.) within 3 months prior to Day -1 and/or
positive urine cotinine test at Screening or Day -1.

- 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
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
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
13/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/06/2022
Sample size
Target
Accrual to date
Final
84
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
XW10508 in healthy volunteers.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04966832
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