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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-29

Study Completion Date

2021-12-14

Brief Summary

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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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XW10172

Group Type EXPERIMENTAL

XW10172

Intervention Type DRUG

Various formulations

Interventions

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XW10172

Various formulations

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes