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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02497924

Enrollment

Registered

2015-07-15

Start date

2015-06-30

Completion date

2016-07-31

Last updated

2017-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Sickle Cell

Brief summary

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.

Interventions

DRUGGBT440

GBT440 capsules followed by single dose of \[C14\] GBT440 oral suspension

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

1. Healthy; non-smoking male; 18 to 55 years old, inclusive 2. Weighs at least 50 kg and not more than 110 kg 3. Agrees to use contraception 4. Willing and able to give written informed consent

Exclusion criteria

1. Evidence or history of clinically significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder 2. History of stomach or intestinal surgery that would potentially alter drug absorption 3. History of hypersensitivity or allergy to drugs, foods, or other substances 4. History or presence of abnormal electrocardiogram 5. Exposure to significant radiation or participated in more than 1 other radiolabeled study drug trial within 12 months of Screening 6. 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

Design outcomes

Primary

Measure	Time frame
Time to peak whole blood and plasma concentration (Tmax)	0 to 168 hours post dose
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
Identification of metabolites in whole blood, plasma, urine, and feces following [C14] GBT440 administration	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

Secondary

Measure	Time frame
Number of participants with adverse events	Baseline to 27 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026