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OpenTrials
Completed

NCT Number: NCT04688580

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

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

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

CMAX

Adelaide, South Australia, 5000, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

XW10172

Drug

Various formulations

Primary outcomes

  1. Maximum concentration (Cmax)

    Time frame: 12 hours

  2. Trough concentration (Cmin)

    Time frame: 12 hours

  3. Area under the concentration-time curve (AUC) from 0 to time of last quantifiable concentration (AUC0-tlast)

    Time frame: 12 hours

  4. AUC from time 0 extrapolated to infinity (AUC0-inf)

    Time frame: 12 hours

  5. AUC over the dosing interval (AUCtau)

    Time frame: 12 hours

  6. Apparent terminal half-life (t1/2)

    Time frame: 12 hours

  7. Cmax and AUC ratios of metabolite to XW10172

    Time frame: 12 hours

  8. Apparent oral clearance (CL/F)

    Time frame: 12 hours

  9. Time to reach Cmax (Tmax)

    Time frame: 12 hours

Secondary outcomes

  1. Incidence, severity, and causality of AEs

    Time frame: Up to 14 Days

Sponsors and collaborators

Lead sponsor

XWPharma

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 30, 2020
Registry last updated
Nov 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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