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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Other: Placebo; Drug: XW10508

• Registration Number: NCT04966832
• Lead Sponsor: XWPharma

Brief Summary

The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of XW10508 in healthy volunteers.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-07-12
• Study First Submitted QC: 2021-07-12
• Study Start: 2021-07-13
• Study First Posted: 2021-07-19
• Primary Completion: 2022-06-13
• Study Completion: 2022-06-13
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo capsules or tablets
XW10508	XW10508	XW10508 capsules or tablets

Primary Outcome Measures

Name	Time	Method
Incidence, severity, and causality of adverse events (AEs)	Up to 12 Days

Secondary Outcome Measures

Name	Time	Method
Cmax and AUC ratios of metabolites to XW10172	48 hours
Time to reach Cmax (Tmax)	48 hours
Maximum concentration (Cmax)	48 hours
Trough concentration (Cmin)	48 hours
Area under the concentration-time curve (AUC) from 0 to time of last quantifiable concentration	48 hours
AUC from time 0 extrapolated to infinity (AUC0-inf)	48 hours
AUC over the dosing interval (AUCtau)	48 hours
Apparent terminal half-life (t1/2)	48 hours

Trial Locations

Locations (1)

CMAX; 🇦🇺 Adelaide, South Australia, Australia