Back to resultsA Study of the Absorption, Metabolism, and Excretion of GBT440 in Healthy Male Subjects
Primary Purpose
Anemia, Sickle Cell
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GBT440
Sponsored by
About this trial
This is an interventional other trial for Anemia, Sickle Cell
Eligibility Criteria
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
Sites / Locations
- Covance Early Clinical Services
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GBT440
Arm Description
GBT440 / [C14] GBT440
Outcomes
Primary Outcome Measures
Area under the whole blood and plasma concentration versus time curve (AUC)
Peak whole blood and plasma concentration (Cmax)
Time to peak whole blood and plasma concentration (Tmax)
Half-life (T 1/2)
Percent total recovery of radioactivity in blood, urine, and feces
Identification of metabolites in whole blood, plasma, urine, and feces following [C14] GBT440 administration
Secondary Outcome Measures
Number of participants with adverse events
Full Information
NCT ID
NCT02497924
First Posted
July 13, 2015
Last Updated
April 10, 2017
Sponsor
Global Blood Therapeutics
1. Study Identification
Unique Protocol Identification Number
NCT02497924
Brief Title
A Study of the Absorption, Metabolism, and Excretion of GBT440 in Healthy Male Subjects
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Global Blood Therapeutics
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Sickle Cell
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GBT440
Arm Type
Experimental
Arm Description
GBT440 / [C14] GBT440
Intervention Type
Drug
Intervention Name(s)
GBT440
Intervention Description
GBT440 capsules followed by single dose of [C14] GBT440 oral suspension
Primary Outcome Measure Information:
Title
Area under the whole blood and plasma concentration versus time curve (AUC)
Time Frame
0 to 648 hours post dose
Title
Peak whole blood and plasma concentration (Cmax)
Time Frame
0 to 168 hours post dose
Title
Time to peak whole blood and plasma concentration (Tmax)
Time Frame
0 to 168 hours post dose
Title
Half-life (T 1/2)
Time Frame
0 to 168 hours post dose
Title
Percent total recovery of radioactivity in blood, urine, and feces
Time Frame
0 to 648 hours post dose
Title
Identification of metabolites in whole blood, plasma, urine, and feces following [C14] GBT440 administration
Time Frame
0 to 168 hours post dose
Secondary Outcome Measure Information:
Title
Number of participants with adverse events
Time Frame
Baseline to 27 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carla Washington, PhD
Organizational Affiliation
Global Blood Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Covance Early Clinical Services
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53704
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of the Absorption, Metabolism, and Excretion of GBT440 in Healthy Male Subjects
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