NCT04688580
Completed
Early Phase 1
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
XWPharma1 site in 1 country46 target enrollmentNovember 29, 2020
Overview
- Phase
- Early Phase 1
- Intervention
- XW10172
- Conditions
- Healthy
- Sponsor
- XWPharma
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Time to reach Cmax (Tmax)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of various formulations of XW10172 in healthy volunteers.
Investigators
Eligibility Criteria
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.
Arms & Interventions
XW10172
Intervention: XW10172
Outcomes
Primary Outcomes
Time to reach Cmax (Tmax)
Time Frame: 12 hours
Maximum concentration (Cmax)
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
Trough concentration (Cmin)
Time Frame: 12 hours
Apparent oral clearance (CL/F)
Time Frame: 12 hours
AUC from time 0 extrapolated to infinity (AUC0-inf)
Time Frame: 12 hours
Cmax and AUC ratios of metabolite to XW10172
Time Frame: 12 hours
AUC over the dosing interval (AUCtau)
Time Frame: 12 hours
Apparent terminal half-life (t1/2)
Time Frame: 12 hours
Secondary Outcomes
- Incidence, severity, and causality of AEs(Up to 14 Days)
Study Sites (1)
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