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A Single-Dose Relative Bioavailability Study Of GBT440 300 mg Capsules in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02567695
Recruitment Status : Completed
First Posted : October 5, 2015
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
Global Blood Therapeutics

Study Description
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Brief Summary:
The purpose of this study is to evaluate the relative bioavailability of a single 300 mg dose of GBT440 administered as a high strength (1 × 300 mg) capsule versus a low strength (3 × 100 mg) capsule formulation in healthy fasted subjects.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Single-Dose, Open-Label, Randomized, Two-Period Crossover Study to Evaluate the Relative Bioavailability of GBT440 300 mg Administered as Capsule Formulations in Healthy Subjects
Actual Study Start Date : September 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment Sequence 1
Treatment A with one 300 mg capsule (high-strength) of GBT440 administered in a fasted state (test) in dosing Period 1 followed by Treatment B with 300 mg (3 × 100 mg) capsules (low-strength) of GBT440 administered in a fasted state (reference) in dosing Period 2.
 Drug: GBT440
Test: GBT440 300 mg capsule (high-strength) Reference: GBT440 100 mg capsule (low-strength)
Experimental: Treatment Sequence 2
Treatment B with 300 mg (3 × 100 mg) capsules (low-strength) of GBT440 administered in a fasted state (reference) in dosing Period 1 followed by Treatment A with one 300 mg capsule (high-strength) of GBT440 administered in a fasted state (test) in dosing Period 2.
 Drug: GBT440
Test: GBT440 300 mg capsule (high-strength) Reference: GBT440 100 mg capsule (low-strength)


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetics (PK): Maximum observed concentration (Cmax) of GBT440 in whole blood [ Time Frame: predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose, and Day 12, Day 20, and Day 28 for each period ]
  2. Pharmacokinetics (PK): Area under the concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUCt) of GBT440 in whole blood [ Time Frame: predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose, and Day 12, Day 20, and Day 28 for each period ]
  3. Pharmacokinetics (PK): AUC from time 0 extrapolated to infinity (AUCinf) of GBT440 in whole blood [ Time Frame: predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose, and Day 12, Day 20, and Day 28 for each period ]

Secondary Outcome Measures :
  1. Pharmacokinetics (PK): The time that Cmax was observed (tmax) of GBT440 in whole blood [ Time Frame: predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose, and Day 12, Day 20, and Day 28 for each period ]
  2. Pharmacokinetics (PK): Terminal elimination half-life (t½) of GBT440 in whole blood [ Time Frame: predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose, and Day 12, Day 20, and Day 28 for each period ]
  3. Pharmacokinetics (PK): Apparent oral clearance (CL/F) of GBT440 in whole blood [ Time Frame: predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose, and Day 12, Day 20, and Day 28 for each period ]
  4. Pharmacokinetics (PK): Apparent volume of distribution during the terminal phase (Vz/F) of GBT440 in whole blood [ Time Frame: predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose, and Day 12, Day 20, and Day 28 for each period ]

Other Outcome Measures:
  1. Treatment-emergent adverse events (TEAEs) and serious adverse events [ Time Frame: Baseline to Period 2 Day 28 ]
  2. Changes in clinical laboratory results [ Time Frame: Baseline to Period 2 Day 28 ]
  3. Changes in physical examination findings [ Time Frame: Baseline to Period 2 Day 28 ]
  4. Changes in vital signs [ Time Frame: Baseline to Period 2 Day 28 ]
  5. Changes in electrocardiograms (ECGs) [ Time Frame: Baseline to Period 2 Day 28 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is a female of non-childbearing potential or male, who is healthy, nonsmoking, and 18 to 60 years old, inclusive, at screening
  • Male subjects agree 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 hypersensitivity or allergy to drugs, foods, or other substances
  • History or presence of abnormal electrocardiogram or hypertension
  • History of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction within 1 year 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
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): NCT02567695


Locations
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United States, Texas
ICON Early Phase Services, LLC Clinical Research Unit
San Antonio, Texas, United States, 78209
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: NCT02567695    
Other Study ID Numbers: GBT440-004
First Posted: October 5, 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