Pharmacokinetics, Safety, and Tolerability of Various XW10172 Oral Formulations in Healthy Adult Volunteers

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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04688580

Enrollment

Registered

2020-12-30

Start date

2020-11-29

Completion date

2021-12-14

Last updated

2022-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

Interventions

DRUGXW10172

Various formulations

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

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.

Design outcomes

Primary

Measure	Time frame
Time to reach Cmax (Tmax)	12 hours
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

Secondary

Measure	Time frame
Incidence, severity, and causality of AEs	Up to 14 Days

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026