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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04688580
• Other study ID #: XW10172-102
• Status: Completed
• Phase: Early Phase 1
• Start date: November 29, 2020
• Est. completion date: December 14, 2021

Study information

• Verified date: November 2022
• Source: XWPharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 14, 2021
• Est. primary completion date: December 14, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• XW10172
Various formulations

Locations

Country	Name	City	State
Australia	CMAX	Adelaide	South Australia

Sponsors (1)

Lead Sponsor	Collaborator
XWPharma

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum concentration (Cmax)		12 hours
Primary	Trough concentration (Cmin)		12 hours
Primary	Area under the concentration-time curve (AUC) from 0 to time of last quantifiable concentration (AUC0-tlast)		12 hours
Primary	AUC from time 0 extrapolated to infinity (AUC0-inf)		12 hours
Primary	AUC over the dosing interval (AUCtau)		12 hours
Primary	Apparent terminal half-life (t1/2)		12 hours
Primary	Cmax and AUC ratios of metabolite to XW10172		12 hours
Primary	Apparent oral clearance (CL/F)		12 hours
Primary	Time to reach Cmax (Tmax)		12 hours
Secondary	Incidence, severity, and causality of AEs		Up to 14 Days