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

Phase 1

Completed

• Conditions: Anemia, Sickle Cell
• Interventions: Drug: GBT440

• Registration Number: NCT02497924
• Lead Sponsor: Global Blood Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-07-13
• Study First Submitted QC: 2015-07-13
• Study First Posted: 2015-07-15
• Status Verified: 2015-09
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Last Update Submitted: 2017-04-10
• Last Update Posted: 2017-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GBT440	GBT440	GBT440 / \[C14\] GBT440

Primary Outcome Measures

Name	Time	Method
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
Area under the whole blood and plasma concentration versus time curve (AUC)	0 to 648 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

Name	Time	Method
Number of participants with adverse events	Baseline to 27 days

Trial Locations

Locations (1)

Covance Early Clinical Services; 🇺🇸 Madison, Wisconsin, United States