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

Early Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: XW10172

• Registration Number: NCT04688580
• Lead Sponsor: XWPharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-14
• Study Start: 2020-11-29
• Study First Submitted QC: 2020-12-24
• Study First Posted: 2020-12-30
• Primary Completion: 2021-12-14
• Study Completion: 2021-12-14
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
XW10172	XW10172	-

Primary Outcome Measures

Name	Time	Method
AUC over the dosing interval (AUCtau)	12 hours
Time to reach Cmax (Tmax)	12 hours
Maximum concentration (Cmax)	12 hours
Area under the concentration-time curve (AUC) from 0 to time of last quantifiable concentration (AUC0-tlast)	12 hours
Trough concentration (Cmin)	12 hours
Apparent oral clearance (CL/F)	12 hours
AUC from time 0 extrapolated to infinity (AUC0-inf)	12 hours
Cmax and AUC ratios of metabolite to XW10172	12 hours
Apparent terminal half-life (t1/2)	12 hours

Secondary Outcome Measures

Name	Time	Method
Incidence, severity, and causality of AEs	Up to 14 Days

Trial Locations

Locations (1)

CMAX; 🇦🇺 Adelaide, South Australia, Australia