Safety, Tolerability and Pharmacokinetics of XW10508 Immediate and Modified Release Formulations in Healthy Adults

Healthy Volunteers Clinical Trial

Official title:

A Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics of XW10508 Immediate and Modified Release Formulations in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04966832
• Other study ID #: XW10508-101
• Status: Completed
• Phase: Phase 1
• Start date: July 13, 2021
• Est. completion date: June 13, 2022

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 XW10508 in healthy volunteers.

Description:

This is a first-in-human single and multiple ascending oral dose pharmacokinetic and safety study where participants will receive either XW10508 or placebo. Both immediate release and modified release formulations will be assessed. Timed blood samples will be collected to assess the pharmacokinetics after the study drug is ingested by the participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: June 13, 2022
• Est. primary completion date: June 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male or 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 (in the opinion of the investigator) gastrointestinal, hepatic, renal, respiratory (e.g., asthma, COPD), cardiovascular (e.g., hypertension), metabolic, psychiatric, neurological, immunological, or endocrine disorders, or allergic disease including drug allergies, including immediate type hypersensitivity to components of the study drug. A history of childhood asthma that has resolved is acceptable.

• Use of tobacco- or nicotine-containing products (e.g., cigarettes, cigars, chewing tobacco, snuff, patches, vaping device, etc.) within 3 months prior to Day -1 and/or positive urine cotinine test at Screening or Day -1.

• 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 Volunteers

Intervention

Drug:
• XW10508
XW10508 capsules or tablets

Other:
• Placebo
Placebo capsules or tablets

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	Incidence, severity, and causality of adverse events (AEs)		Up to 12 Days
Secondary	Maximum concentration (Cmax)		48 hours
Secondary	Trough concentration (Cmin)		48 hours
Secondary	Area under the concentration-time curve (AUC) from 0 to time of last quantifiable concentration		48 hours
Secondary	AUC from time 0 extrapolated to infinity (AUC0-inf)		48 hours
Secondary	AUC over the dosing interval (AUCtau)		48 hours
Secondary	Apparent terminal half-life (t1/2)		48 hours
Secondary	Cmax and AUC ratios of metabolites to XW10172		48 hours
Secondary	Time to reach Cmax (Tmax)		48 hours