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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

Tracking Information
First Submitted Date  ICMJE September 30, 2015
First Posted Date  ICMJE October 5, 2015
Last Update Posted Date April 12, 2017
Actual Study Start Date  ICMJE September 2015
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2015)
  • 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 ]
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2015)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 1, 2015)
  • Treatment-emergent adverse events (TEAEs) and serious adverse events [ Time Frame: Baseline to Period 2 Day 28 ]
  • Changes in clinical laboratory results [ Time Frame: Baseline to Period 2 Day 28 ]
  • Changes in physical examination findings [ Time Frame: Baseline to Period 2 Day 28 ]
  • Changes in vital signs [ Time Frame: Baseline to Period 2 Day 28 ]
  • Changes in electrocardiograms (ECGs) [ Time Frame: Baseline to Period 2 Day 28 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Single-Dose Relative Bioavailability Study Of GBT440 300 mg Capsules in Healthy Subjects
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sickle Cell Disease
Intervention  ICMJE Drug: GBT440
Test: GBT440 300 mg capsule (high-strength) Reference: GBT440 100 mg capsule (low-strength)
Study Arms  ICMJE
  • 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.
    Intervention: Drug: GBT440
  • 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.
    Intervention: Drug: GBT440
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 1, 2015)
26
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02567695
Other Study ID Numbers  ICMJE GBT440-004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Global Blood Therapeutics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Global Blood Therapeutics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Carla Washington, PhD Global Blood Therapeutics
PRS Account Global Blood Therapeutics
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP