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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: XW10508; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • CMAX

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: XW10508; XW10508 capsules or tablets	Drug: XW10508; XW10508 capsules or tablets
PLACEBO_COMPARATOR: Placebo; Placebo capsules or tablets	Other: Placebo; Placebo capsules or tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence, severity, and causality of adverse events (AEs)	Up to 12 Days

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Cmax and AUC ratios of metabolites to XW10172	48 hours
Time to reach Cmax (Tmax)	48 hours

Collaborators and Investigators

• Sponsor: XWPharma
• Investigators: Study Director: Daniel M Canafax, PharmD, XWPharma

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 13, 2021
• Primary Completion (ACTUAL): June 13, 2022
• Study Completion (ACTUAL): June 13, 2022

Study Registration Dates

• First Submitted: July 12, 2021
• First Submitted That Met QC Criteria: July 12, 2021
• First Posted (ACTUAL): July 19, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 4, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: XW10508-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No