A Study of [14C]GB491 in Male Healthy Subjects

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

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-14

Study Completion Date

2022-11-14

Brief Summary

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This is an open-label, single-center study to evaluate the mass-balance and pharmacokinetics of GB491 in 4-8 healthy male subjects receiving a single oral 150mg dose of GB491 containing approximately 50 uCi of \[14C\]GB491. This study will help understand how the drug appears in the blood, urine, and feces after it is administered.

In addition, this study will also evaluate the safety of a single dose of \[14C\]GB491 when given to healthy subjects.

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Detailed Description

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Conditions

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Breast Cancer Nonsmall Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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[14C]GB491

Group Type EXPERIMENTAL

[14C]GB491

Intervention Type DRUG

A single 150mg dose of GB491 containing approximately 50 uCi of \[14C\]GB491.

Interventions

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[14C]GB491

A single 150mg dose of GB491 containing approximately 50 uCi of \[14C\]GB491.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* A healthy male volunteer between 18 and 50 years of age inclusive
* A total body weight \>=50kg, and a BMI of 19.0-26.0 kg/m2
* A signed informed consent document

Exclusion Criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
* Subjects with HBsAg-positive, or HCV-Ab-positive, or TPPA-positive, or HIV infection
* Subjects with a history of habitual constipation/diarrhea, irritable bowel syndrome, or inflammatory bowel disease

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes