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
Time to reach Cmax (Tmax)	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
AUC over the dosing interval (AUCtau)	12 hours
Maximum concentration (Cmax)	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