HealthyEarly Phase 1NCT04688580
Pharmacokinetics, Safety, and Tolerability of Various XW10172 Oral Formulations in Healthy Adult Volunteers
A Early Phase 1 study testing XW10172 in people with Healthy, run by XWPharma at 1 site in Australia.
Trial summary
The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of various formulations of XW10172 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- XW10172
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteAustralia
- Study dates
- 29 Nov 2020to 14 Dec 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of various formulations of XW10172 in healthy volunteers.
- Conditions
- Healthy
- Being tested
- XW10172
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XW10172Drug
Various formulations
| Study group | Role | What they receive |
|---|---|---|
| XW10172 | Experimental | Not described Receives: Drug: XW10172 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration (Cmax)
Measured: 12 hours
Trough concentration (Cmin)
Measured: 12 hours
Area under the concentration-time curve (AUC) from 0 to time of last quantifiable concentration (AUC0-tlast)
Measured: 12 hours
AUC from time 0 extrapolated to infinity (AUC0-inf)
Measured: 12 hours
AUC over the dosing interval (AUCtau)
Measured: 12 hours
Apparent terminal half-life (t1/2)
Measured: 12 hours
Cmax and AUC ratios of metabolite to XW10172
Measured: 12 hours
Apparent oral clearance (CL/F)
Measured: 12 hours
Time to reach Cmax (Tmax)
Measured: 12 hours
Secondary outcomes (1)
Incidence, severity, and causality of AEs
Measured: Up to 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start29 Nov 2020
- Primary completion14 Dec 2021
- Study completion14 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- XWPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel M. Canafax, PharmD, Study director, XWPharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04688580
- Sponsor's protocol ID
- XW10172-102
- Status last verified
- Nov 2022
- First submitted
- 14 Nov 2020
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04688580
- Acronym / sponsor ID
- XW10172-102
- Conditions
- Healthy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- XWPharmaIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2020 (actual)
- Primary completion
- 14 Dec 2021 (actual)
- Study completion
- 14 Dec 2021 (actual)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of various formulations of XW10172 in healthy volunteers.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XW10172 | Experimental | Drug: XW10172 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XW10172Various formulations | Drug | XW10172 |
Primary outcome
Maximum concentration (Cmax)
Time frame: 12 hours
Trough concentration (Cmin)
Time frame: 12 hours
Area under the concentration-time curve (AUC) from 0 to time of last quantifiable concentration (AUC0-tlast)
Time frame: 12 hours
AUC from time 0 extrapolated to infinity (AUC0-inf)
Time frame: 12 hours
AUC over the dosing interval (AUCtau)
Time frame: 12 hours
Apparent terminal half-life (t1/2)
Time frame: 12 hours
Cmax and AUC ratios of metabolite to XW10172
Time frame: 12 hours
Apparent oral clearance (CL/F)
Time frame: 12 hours
Time to reach Cmax (Tmax)
Time frame: 12 hours
1 secondary outcome
Incidence, severity, and causality of AEs
Time frame: Up to 14 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel M. Canafax, PharmD study director
XWPharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing XW10172 in people with Healthy, run by XWPharma at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum concentration (Cmax) (time frame: 12 hours). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.