Healthy Volunteers
Conditions
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.
Interventions
DRUGXW10508
XW10508 capsules or tablets
OTHERPlacebo
Placebo capsules or tablets
Sponsors
XWPharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
In this double-blind study, participants will be randomized to XW10508 or placebo.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence, severity, and causality of adverse events (AEs) | Up to 12 Days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Maximum concentration (Cmax) | 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 |
| AUC over the dosing interval (AUCtau) | 48 hours |
Countries
Australia
Outcome results
None listed