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The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of XW10508 in healthy volunteers.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XW10508 | Experimental | XW10508 capsules or tablets |
|
| Placebo | Placebo Comparator | Placebo capsules or tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XW10508 | Drug | XW10508 capsules or tablets |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence, severity, and causality of adverse events (AEs) | Up to 12 Days |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel M Canafax, PharmD | XWPharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMAX | Adelaide | South Australia | 5000 | Australia |
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In this double-blind study, participants will be randomized to XW10508 or placebo.
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| Other |
Placebo capsules or tablets |
|
| 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 |