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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04688580
Recruitment Status : Recruiting
First Posted : December 30, 2020
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
XWPharma

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

Condition or disease Intervention/treatment Phase
Healthy Drug: XW10172 Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official 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
Actual Study Start Date : November 29, 2020
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : October 31, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: XW10172 Drug: XW10172
Various formulations


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Incidence, severity, and causality of AEs [ Time Frame: Up to 14 Days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04688580


Contacts
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Contact: Beth A Zib 650-885-9682 Beth.Zib@XWPharma.com

Locations
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Australia, South Australia
CMAX Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Alexandra Evans         
Sponsors and Collaborators
XWPharma
Investigators
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Study Director: Daniel M. Canafax, PharmD XWPharma
More Information
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Responsible Party: XWPharma
ClinicalTrials.gov Identifier: NCT04688580    
Other Study ID Numbers: XW10172-102
First Posted: December 30, 2020    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No