Clinical trial NCT04966832: Safety, Tolerability and Pharmacokinetics of XW10508 Immediate and Modified Release Formulations in Healthy Adults
Official title: A Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics of XW10508 Immediate and Modified Release Formulations in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: XWPharma
Sponsor class: INDUSTRY
First posted: 2021-07-19
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this double-blind study, participants will be randomized to XW10508 or placebo.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence, severity, and causality of adverse events (AEs)
timeFrame: Up to 12 Days
Secondary outcomes:
measure: Maximum concentration (Cmax)
timeFrame: 48 hours
measure: Trough concentration (Cmin)
timeFrame: 48 hours
measure: Area under the concentration-time curve (AUC) from 0 to time of last quantifiable concentration
timeFrame: 48 hours
measure: AUC from time 0 extrapolated to infinity (AUC0-inf)
timeFrame: 48 hours
measure: AUC over the dosing interval (AUCtau)
timeFrame: 48 hours
measure: Apparent terminal half-life (t1/2)
timeFrame: 48 hours
measure: Cmax and AUC ratios of metabolites to XW10172
timeFrame: 48 hours
measure: Time to reach Cmax (Tmax)
timeFrame: 48 hours
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: CMAX
state: South Australia
Study officials:
affiliation: XWPharma
name: Daniel M Canafax, PharmD
role: STUDY_DIRECTOR
References: