A Study of the Absorption, Metabolism, and Excretion of GBT440 in Healthy Male Subjects

Study Overview
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Brief Summary
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This study will provide information regarding the metabolic pathway of GBT440, the need for evaluation of potential drug-drug interactions, and the need for studies in special populations. The administration of radiolabeled drug is necessary to fully characterize the rates and routes of elimination of GBT440, providing further quantitative information on the disposition of GBT440. The results from this study will permit a comprehensive comparison between animal and human routes of elimination and metabolic profiles of GBT440.

Official Title
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A Phase 1 Study to Investigate Absorption, Metabolism, and Excretion After Establishment of Steady State Via GBT440 Loading and Maintenance Dosing Followed by a Single Oral Dose Administration of [14C]-GBT440 in Healthy Male Subjects

Conditions
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Anemia, Sickle Cell

Intervention / Treatment
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* Drug: GBT440


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy; non-smoking male; 18 to 55 years old, inclusive Weighs at least 50 kg and not more than 110 kg Agrees to use contraception Willing and able to give written informed consent Exclusion Criteria: Evidence or history of clinically significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder History of stomach or intestinal surgery that would potentially alter drug absorption History of hypersensitivity or allergy to drugs, foods, or other substances History or presence of abnormal electrocardiogram Exposure to significant radiation or participated in more than 1 other radiolabeled study drug trial within 12 months of Screening Participated in another clinical trial of an investigational drug within 30 days (or 5 half-lives of the investigational drug, whichever is longer) prior to Screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GBT440<br>GBT440 / [C14] GBT440 | Drug: GBT440<br>* GBT440 capsules followed by single dose of [C14] GBT440 oral suspension<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the whole blood and plasma concentration versus time curve (AUC) |  | 0 to 648 hours post dose | 
| Peak whole blood and plasma concentration (Cmax) |  | 0 to 168 hours post dose | 
| Time to peak whole blood and plasma concentration (Tmax) |  | 0 to 168 hours post dose | 
| Half-life (T 1/2) |  | 0 to 168 hours post dose | 
| Percent total recovery of radioactivity in blood, urine, and feces |  | 0 to 648 hours post dose | 
| Identification of metabolites in whole blood, plasma, urine, and feces following [C14] GBT440 administration |  | 0 to 168 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | Baseline to 27 days |