Safety, Tolerability and Pharmacokinetics of XW10508 Immediate and Modified Release Formulations in Healthy Adults

XWPharma

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Other: Placebo

Drug: XW10508

Study type

Interventional

Funder types

Industry

Identifiers

NCT04966832

XW10508-101

Details and patient eligibility

About

The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of XW10508 in healthy volunteers.

Full 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.

Enrollment

84 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.