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Drug Interaction Study of GBT440 With Caffeine, S-warfarin, Omeprazole, and Midazolam in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02567682
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 to evaluate the effect of concomitant administration of GBT440 on caffeine (a CYP1A2 probe substrate), S warfarin (a CYP2C9 probe substrate), omeprazole (a CYP2C19 probe substrate), and midazolam (a CYP3A4 probe substrate) plasma concentrations.

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 : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label Study to Evaluate the Effect of Multiple Doses of GBT440 on the Pharmacokinetics of Probe Substrates for CYP1A2, CYP2C9, CYP2C19, and CYP3A4 in Healthy Subjects
Study Start Date : September 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Fixed sequence, 2-periods
An open-label, fixed sequence, 2-period drug interaction study Period 1 Treatment A: Single dose of drug cocktail on Day 1 Period 2 Treatment B: GBT440 on Days 1 through 3 and Treatment C: Single dose of drug cocktail on Day 4 and GBT440 on Days 4 through 7
 Drug: GBT440
GBT440 capsules followed by Caffeine, S-warfarin+vitamin K, Omeprazole, and Midazolam


Outcome Measures
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Primary Outcome Measures :
  1. Peak plasma concentration(Cmax) for caffeine, S warfarin, omeprazole, and midazolam in plasma [ Time Frame: 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2 ]
  2. Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUCt) for caffeine, S warfarin, omeprazole, and midazolam [ Time Frame: 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2 ]
  3. Area under the plasma concentration time curve from time 0 extrapolated to infinity (AUCinf) for caffeine, S warfarin, omeprazole, and midazolam [ Time Frame: 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2 ]

Secondary Outcome Measures :
  1. The time that Cmax was observed (tmax) for caffeine, S warfarin, omeprazole, and midazolam in plasma [ Time Frame: 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2 ]
  2. Terminal elimination half-life (t½) for caffeine, S warfarin, omeprazole, and midazolam in plasma [ Time Frame: 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2 ]
  3. Cmax for metabolites of caffeine, warfarin, omeprazole, and midazolam in plasma [ Time Frame: 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2 ]
  4. tmax, for metabolites of caffeine, warfarin, omeprazole, and midazolam in plasma [ Time Frame: 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2 ]
  5. AUCt for metabolites of caffeine, warfarin, omeprazole, and midazolam in plasma [ Time Frame: 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2 ]
  6. AUCinf for metabolites of caffeine, warfarin, omeprazole, and midazolam in plasma [ Time Frame: 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2 ]
  7. t1/2 for metabolites of caffeine, warfarin, omeprazole, and midazolam in plasma [ Time Frame: 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2 ]
  8. Ratio of metabolite to parent Cmax corrected for molecular weight (Cmax M/P) for metabolites of caffeine, warfarin, omeprazole, and midazolam in plasma [ Time Frame: 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2 ]
  9. Ratio of metabolite to parent AUCt corrected for molecular weight (AUCt M/P)for metabolites of caffeine, warfarin, omeprazole, and midazolam in plasma [ Time Frame: 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2 ]
  10. Ratio of metabolite to parent AUCinf corrected for molecular weight (AUCinf M/P) for metabolites of caffeine, warfarin, omeprazole, and midazolam in plasma [ Time Frame: 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2 ]
  11. Cmax for GBT440 in whole blood and plasma [ Time Frame: 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2 ]
  12. tmax for GBT440 in whole blood and plasma [ Time Frame: 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2 ]
  13. AUC from time 0 to 24 hours (AUC0-24) (Days 4 and 7) for GBT440 in whole blood and plasma [ Time Frame: 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2 ]
  14. t1/2 (Day7) for GBT440 in whole blood and plasma [ Time Frame: 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2 ]

Other Outcome Measures:
  1. Treatment-emergent adverse events (TEAEs) and serious adverse events [ Time Frame: Baseline to Period 2 Day 25 ]
  2. Change in clinical laboratory tests [ Time Frame: Baseline to Period 2 Day 25 ]
  3. Change in physical examination findings [ Time Frame: Baseline to Period 2 Day 25 ]
  4. Change in vital signs [ Time Frame: Baseline to Period 2 Day 25 ]
  5. Change in pulse oximetry findings [ Time Frame: Baseline to Period 2 Day 25 ]
  6. Change in electrocardiograms (ECGs) [ Time Frame: Baseline to Period 2 Day 25 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 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 55 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): NCT02567682


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: NCT02567682    
Other Study ID Numbers: GBT440-003
First Posted: October 5, 2015    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017
Keywords provided by Global Blood Therapeutics:
anemia, sickle cell
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn