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

NCT04966832 | Completed Phase 1 DMC

• 1 other identifier: XW10508-101
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Incidence, severity, and causality of adverse events (AEs)

  Up to 12 Days

Secondary Outcomes (8)

• 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

Study Arms (2)

XW10508

EXPERIMENTAL

XW10508 capsules or tablets

Drug: XW10508

Placebo

PLACEBO COMPARATOR

Placebo capsules or tablets

Other: Placebo

Interventions

XW10508 DRUG

XW10508 capsules or tablets

XW10508

Placebo OTHER

Placebo capsules or tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• XWPharma: lead

Study Sites (1)

CMAX

Adelaide, South Australia, 5000, Australia

Location

Study Officials

• Daniel M Canafax, PharmD

  XWPharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: In this double-blind study, participants will be randomized to XW10508 or placebo.

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 19, 2021
• Study Start: July 13, 2021
• Primary Completion: June 13, 2022
• Study Completion: June 13, 2022
• Last Updated: November 4, 2022

Record last verified: 2022-11

Locations

AU (1)