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

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ClinicalTrials.gov Identifier: NCT02497924
Recruitment Status : Completed
First Posted : July 15, 2015
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
Global Blood Therapeutics

Study Description
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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.

Condition or disease Intervention/treatment Phase
Anemia, Sickle Cell Drug: GBT440 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : June 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: GBT440
GBT440 / [C14] GBT440
 Drug: GBT440
GBT440 capsules followed by single dose of [C14] GBT440 oral suspension


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

Secondary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: Baseline to 27 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02497924


Locations
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United States, Wisconsin
Covance Early Clinical Services
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Global Blood Therapeutics
Investigators
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Study Director: Carla Washington, PhD Global Blood Therapeutics
More Information
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Responsible Party: Global Blood Therapeutics
ClinicalTrials.gov Identifier: NCT02497924    
Other Study ID Numbers: GBT440-002
First Posted: July 15, 2015    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: September 2015
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn